Trial Outcomes & Findings for A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer (NCT NCT02443324)

Last Updated: 2024-07-31

Results Overview

DLT is defined as an Adverse Event (AE) that is likely related to study medication or combination,and fulfills any one of following criteria:Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade (Gr) 3 and 4 nonlaboratory toxicity (tox),Any Gr 3 or 4 laboratory value if medical intervention is required to treat participant (pt) or abnormality persists for \>1 week;Hematologic tox:Gr 4 toxicity lasting ≥ 7 days,or Gr 3 thrombocytopenia if associated with bleeding and requires platelet transfusion,or Febrile neutropenia Gr 3 or Gr 4;GR 5 tox (death);Any toxicity that is possibly related to study treatment that requires withdrawal of pt from study during Cycle 1,A delay of \> 14 days due to persistent Grade ≥ 2 toxicities in initiating Cycle 2,with exception of Grade 2 fatigue;Any infusion or hypersensitivity reactions are NOT a DLT. A summary of other nonserious AEs and all Serious AEs,regardless of causality is located in Reported Adverse Event section.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

175 participants

Primary outcome timeframe

Cycle 1 (21 Days)

Results posted on

2024-07-31

Participant Flow

This study has Phase 1a (dose-limiting toxicity \[DLT\] observation) and expansion Phase 1b (safety and preliminary efficacy) included participants with 2 dosing schedules: Schedule 1: gastroesophageal junction (GEJ) cancer (Cohorts A, A2) and biliary tract cancer (Cohorts A1); Schedule 2: Gastric-GEJ cancer (Cohort B), nonsmall cell lung cancer (NSCLC) (Cohorts C, E), and urothelial cancer (Cohort D).

Participants who did not "complete" study were those who discontinued study treatment by the time of study completion.

Participant milestones

Participant milestones
Measure	Cohort A Participants with Gastric-GEJ cancer \[Second-Third Line (L)\] received 8 milligrams per kilogram (mg/kg) ramucirumab given intravenously (IV) on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 for every 3 weeks (Q3W) of a 21-day cycle.	Cohort A1 Participants with BTC cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort A2 Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort B Participants with Gastric-GEJ cancer (Second-Third L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Overall Study STARTED	24	26	29	17	28	24	27
Overall Study Received at Least One Dose of Study Drug	24	26	28	17	27	24	26
Overall Study Phase 1a	8	0	0	0	3	0	0
Overall Study Phase 1b	16	26	28	17	24	24	26
Overall Study COMPLETED	0	1	4	1	7	0	8
Overall Study NOT COMPLETED	24	25	25	16	21	24	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A Participants with Gastric-GEJ cancer \[Second-Third Line (L)\] received 8 milligrams per kilogram (mg/kg) ramucirumab given intravenously (IV) on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 for every 3 weeks (Q3W) of a 21-day cycle.	Cohort A1 Participants with BTC cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort A2 Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort B Participants with Gastric-GEJ cancer (Second-Third L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Overall Study Death	4	1	0	3	1	3	2
Overall Study Lost to Follow-up	0	0	0	1	0	1	0
Overall Study Physician Decision	0	3	5	1	1	0	2
Overall Study Progressive Disease	20	20	13	10	13	17	10
Overall Study Withdrawal by Subject	0	0	3	1	1	0	1
Overall Study Adverse Event	0	1	3	0	4	3	3
Overall Study Enrolled but Never Treated	0	0	1	0	1	0	1

Baseline Characteristics

A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A n=24 Participants Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort A1 n=26 Participants Participants with BTC cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort A2 n=28 Participants Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort B n=17 Participants Participants with Gastric-GEJ cancer (Second-Third L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C n=27 Participants Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D n=24 Participants Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E n=26 Participants Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Total n=172 Participants Total of all reporting groups
Age, Continuous	56.0 years n=5 Participants	62.5 years n=7 Participants	63.0 years n=5 Participants	61.0 years n=4 Participants	65.0 years n=21 Participants	63.0 years n=10 Participants	63.0 years n=115 Participants	61.28 years n=6 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	18 Participants n=7 Participants	7 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	10 Participants n=10 Participants	14 Participants n=115 Participants	65 Participants n=6 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants	14 Participants n=4 Participants	21 Participants n=21 Participants	14 Participants n=10 Participants	12 Participants n=115 Participants	107 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=10 Participants	0 Participants n=115 Participants	20 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	19 Participants n=7 Participants	16 Participants n=5 Participants	12 Participants n=4 Participants	21 Participants n=21 Participants	10 Participants n=10 Participants	25 Participants n=115 Participants	123 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	10 Participants n=10 Participants	1 Participants n=115 Participants	29 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 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	1 Participants n=6 Participants
Race (NIH/OMB) Asian	3 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	4 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	4 Participants n=6 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	23 Participants n=7 Participants	17 Participants n=5 Participants	16 Participants n=4 Participants	26 Participants n=21 Participants	22 Participants n=10 Participants	22 Participants n=115 Participants	145 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	1 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	3 Participants n=115 Participants	18 Participants n=6 Participants
Region of Enrollment United States	3 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants	8 Participants n=4 Participants	4 Participants n=21 Participants	8 Participants n=10 Participants	11 Participants n=115 Participants	47 Participants n=6 Participants
Region of Enrollment United Kingdom	15 Participants n=5 Participants	11 Participants n=7 Participants	7 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=10 Participants	6 Participants n=115 Participants	51 Participants n=6 Participants
Region of Enrollment France	2 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	1 Participants n=4 Participants	8 Participants n=21 Participants	2 Participants n=10 Participants	2 Participants n=115 Participants	25 Participants n=6 Participants
Region of Enrollment Germany	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	5 Participants n=115 Participants	8 Participants n=6 Participants
Region of Enrollment Spain	4 Participants n=5 Participants	9 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	13 Participants n=21 Participants	8 Participants n=10 Participants	2 Participants n=115 Participants	41 Participants n=6 Participants

PRIMARY outcome

Timeframe: Cycle 1 (21 Days)

Population: All enrolled participants who received at least one dose of the study drug in dose escalation phase and experienced a DLT. DLT was assessed in Phase 1a of Cohorts A and C during Cycle 1.

Outcome measures

Outcome measures
Measure	Cohort A n=6 Participants Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C n=3 Participants Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort A2 Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Phase 1a: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)	1 participants	0 participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to Measured Progressive Disease (Up to 24 Months)

Population: All enrolled participants who received at least one dose of the study drug. Per Protocol, Cohort A and B participants \[Gastric-GEJ cancer (Second-Third L)\] were combined and outcome data was analyzed under a single arm (Cohort A and B).

Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants per cohort with at least 1 measurable lesion, multiplied by 100. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

Outcome measures

Outcome measures
Measure	Cohort A n=41 Participants Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C n=26 Participants Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort A2 n=28 Participants Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C n=27 Participants Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D n=24 Participants Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E n=26 Participants Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Phase 1a and 1b: Percentage of Participants Who Achieve Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]	7.3 percentage of participants Interval 1.5 to 19.9	3.8 percentage of participants Interval 0.1 to 19.6	25.0 percentage of participants Interval 10.7 to 44.9	29.6 percentage of participants Interval 13.8 to 50.2	12.5 percentage of participants Interval 2.7 to 32.4	42.3 percentage of participants Interval 23.4 to 63.1	—	—	—

SECONDARY outcome

Timeframe: Baseline to Measured Progressive Disease (Up to 24 Months)

Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. Participants who do not have any postbaseline tumor response assessments for any reason were considered.

Outcome measures

Outcome measures
Measure	Cohort A n=41 Participants Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C n=26 Participants Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort A2 n=28 Participants Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C n=27 Participants Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D n=24 Participants Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E n=26 Participants Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Phase 1a and 1b: Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)]	51.2 percentage of participants Interval 35.1 to 67.1	38.5 percentage of participants Interval 20.2 to 59.4	67.9 percentage of participants Interval 47.6 to 84.1	85.2 percentage of participants Interval 66.3 to 95.8	50.0 percentage of participants Interval 29.1 to 70.9	84.6 percentage of participants Interval 65.1 to 95.6	—	—	—

SECONDARY outcome

Timeframe: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)

The duration of response is defined only for responders (patients with a confirmed CR or PR). It is measured from the date of first evidence of a confirmed CR or PR to the date of objective progression or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, DoR will be censored at the date of the last complete objective progression-free disease assessment (CR or PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.

Outcome measures

Outcome measures
Measure	Cohort A n=3 Participants Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C n=1 Participants Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort A2 n=7 Participants Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C n=8 Participants Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D n=3 Participants Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E n=11 Participants Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Phase 1a and 1b: Duration of Response (DoR)	6.7 months Interval 4.4 to 17.5	6.0 months Only 1 participant had PR, therefore 95% Confidence Interval was not calculable.	NA months Interval 9.7 to Median and the upper 95% confidence interval was not achieved due to high censoring rate.	NA months Interval 11.1 to Median and the upper 95% confidence interval was not achieved due to high censoring rate.	8.3 months Interval 4.6 to 16.8	NA months Interval 5.2 to Median and the upper 95% confidence interval was not achieved due to high censoring rate.	—	—	—

SECONDARY outcome

Timeframe: Baseline to Date of CR or PR (Up to 24 Months)

TTR is defined as the time from the date of first study treatment until the first evidence of a confirmed CR or PR.

Outcome measures

Outcome measures
Measure	Cohort A n=3 Participants Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C n=1 Participants Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort A2 n=7 Participants Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C n=8 Participants Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D n=3 Participants Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E n=11 Participants Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Phase 1a and 1b: Time to First Response (TTR)	1.4 months Interval 1.4 to 4.1	2.7 months Only 1 participant had PR, therefore 95% Confidence Interval was not calculable.	2.7 months Interval 1.3 to 2.8	2.1 months Interval 1.3 to 3.0	2.8 months Interval 1.3 to 5.5	1.4 months Interval 1.2 to 3.0	—	—	—

SECONDARY outcome

Timeframe: Baseline to PD or Death of Any Cause (Up to 24 Months)

Population: All enrolled participants who received at least one dose of the study drug. Censored participants: Cohort A and B = 3; Cohort A1 = 4; Cohort A2 = 8; Cohort C = 10; Cohort D = 3 and Cohort E = 13. Per Protocol, Cohort A and B participants \[Gastric-GEJ cancer (Second-Third L)\] were combined and outcome data was analyzed under a single arm (Cohort A and B).

PFS is defined as the time from the date of first study treatment until the date of the first observed radiographically documented progressive disease (PD) or death due to any cause, whichever is earlier. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.

Outcome measures

Outcome measures
Measure	Cohort A n=41 Participants Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C n=26 Participants Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort A2 n=28 Participants Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C n=27 Participants Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D n=24 Participants Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E n=26 Participants Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Phase 1a and 1b: Progression Free Survival (PFS)	2.5 months Interval 1.5 to 4.2	1.6 months Interval 1.4 to 2.8	5.6 months Interval 2.7 to 11.5	9.7 months Interval 4.6 to 27.6	1.9 months Interval 1.2 to 2.8	9.3 months Interval 4.0 to upper 95% confidence interval was not achieved due to high censoring rate.	—	—	—

SECONDARY outcome

Timeframe: Baseline to Death from Any Cause (Up to 24 Months)

Population: All enrolled participants who received at least one dose of the study drug. Censored participants: Cohort A and B = 8; Cohort A1 = 8; Cohort A2 = 12; Cohort C = 12; Cohort D = 6 and Cohort E = 18. Per Protocol, Cohort A and B participants \[Gastric-GEJ cancer (Second-Third L)\] were combined and outcome data was analyzed under a single arm (Cohort A and B).

The OS time is defined as the time from baseline to the date of death from any cause. If a participant is not known to have died on or before the date of data cut-off, OS data will be censored on the last date (on or before the cut-off date) the participant was known to be alive.

Outcome measures

Outcome measures
Measure	Cohort A n=41 Participants Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C n=26 Participants Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort A2 n=28 Participants Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C n=27 Participants Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D n=24 Participants Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E n=26 Participants Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Phase 1a and 1b: Overall Survival (OS)	5.9 months Interval 4.4 to 10.6	6.4 months Interval 4.2 to 13.3	14.6 months Interval 5.4 to upper 95% confidence interval was not achieved due to high censoring rate.	26.2 months Interval 11.8 to upper 95% confidence interval was not achieved due to high censoring rate.	6.4 months Interval 2.5 to 18.7	NA months Interval 13.2 to Median and the upper 95% confidence interval was not achieved due to high censoring rate.	—	—	—

SECONDARY outcome

Timeframe: Phase 1a (Gastric-GEJ or BTC participants (pts)): Week (Wk) 1, 3, 6 and 9; Phase 1a (Gastric, NSCLC, or urothelial pts): Wk 3, 6, 9 and 12; Cohort A, A1, A2: Wk 1, 3, 6, 9, 12, 18, 19 and 24; Cohort B,C,D,E: Wk 3, 6, 9, 12, 18, 19 and 24

Population: All enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data. PK was assessed both in Phase 1a and 1b as per protocol analysis.

PK: Cmin of Ramucirumab following administration every 3 weeks.

Outcome measures

Outcome measures
Measure	Cohort A n=6 Participants Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C n=3 Participants Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort A2 n=16 Participants Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C n=22 Participants Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D n=26 Participants Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E n=15 Participants Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C n=23 Participants Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D n=15 Participants Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E n=21 Participants Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Phase 1a and 1b: Pharmacokinetics (PK): Minimum Trough Concentration (Cmin) of Ramucirumab Week 1	50.9 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 24	—	44.2 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 28	45.2 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 41	45.9 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 23	—	—	—	—
Phase 1a and 1b: Pharmacokinetics (PK): Minimum Trough Concentration (Cmin) of Ramucirumab Week 3	52 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 29	20.9 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 35	40 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 48	44.1 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 57	45.2 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 32	13.3 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 93	22.5 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 62	20.9 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 54	15.6 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 70
Phase 1a and 1b: Pharmacokinetics (PK): Minimum Trough Concentration (Cmin) of Ramucirumab Week 6	69 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 29	NA micrograms/milliliter (μg/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 21.2 μg/mL, 30.6 μg/mL	79.8 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 30	69.1 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 68	61 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 38	25.7 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 74	33.8 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 68	23.3 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 102	19.3 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 115
Phase 1a and 1b: Pharmacokinetics (PK): Minimum Trough Concentration (Cmin) of Ramucirumab Week 9	NA micrograms/milliliter (μg/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 45.6 μg/mL, 72.5 μg/mL	32.7 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 20.6	72.8 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 46	94.3 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 40	78.8 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 31	32.7 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 60	40.1 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 63	34.8 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 73	28.6 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 90
Phase 1a and 1b: Pharmacokinetics (PK): Minimum Trough Concentration (Cmin) of Ramucirumab Week 12	—	NA micrograms/milliliter (μg/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 26.9 μg/mL, 38.7 μg/mL	89.3 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 35	NA micrograms/milliliter (μg/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 140 μg/mL, 160 μg/mL	80.2 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 38	36.8 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 48	47.1 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 45	34.9 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 141	26.3 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 89
Phase 1a and 1b: Pharmacokinetics (PK): Minimum Trough Concentration (Cmin) of Ramucirumab Week 18	—	—	92.4 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 71	NA micrograms/milliliter (μg/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 147 μg/mL, 171 μg/mL	87.6 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 48	52.7 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 45	44.4 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 31	52.6 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 36	37.1 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 66
Phase 1a and 1b: Pharmacokinetics (PK): Minimum Trough Concentration (Cmin) of Ramucirumab Week 19	—	—	149 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 69	NA micrograms/milliliter (μg/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =1. Individual value = 215 μg/mL	120 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 34	—	—	—	—
Phase 1a and 1b: Pharmacokinetics (PK): Minimum Trough Concentration (Cmin) of Ramucirumab Week 24	—	—	116 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 83	NA micrograms/milliliter (μg/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =1. Individual value = 178 μg/mL	95.7 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 27	43.6 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 40	45 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 29	NA micrograms/milliliter (μg/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 39.5 μg/mL, 88 μg/mL	42.1 micrograms/milliliter (μg/mL) Geometric Coefficient of Variation 87

Adverse Events

Cohort A

Serious events: 10 serious events

Other events: 23 other events

Deaths: 21 deaths

Cohort A1

Serious events: 15 serious events

Other events: 26 other events

Deaths: 19 deaths

Cohort A2

Serious events: 16 serious events

Other events: 28 other events

Deaths: 17 deaths

Cohort B

Serious events: 10 serious events

Other events: 16 other events

Deaths: 13 deaths

Cohort C

Serious events: 15 serious events

Other events: 27 other events

Deaths: 16 deaths

Cohort D

Serious events: 16 serious events

Other events: 24 other events

Deaths: 18 deaths

Cohort E

Serious events: 14 serious events

Other events: 26 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A n=24 participants at risk Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort A1 n=26 participants at risk Participants with BTC cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort A2 n=28 participants at risk Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort B n=17 participants at risk Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C n=27 participants at risk Participants with NSCLC (Second-Fourth L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D n=24 participants at risk Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E n=26 participants at risk Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Nervous system disorders Dizziness	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Limbic encephalitis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Metabolic encephalopathy	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Anaemia	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Acute coronary syndrome	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Acute myocardial infarction	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Angina pectoris	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Atrial fibrillation	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Cardiac failure	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Cardiac failure congestive	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Coronary artery stenosis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Myocardial infarction	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Pericardial effusion	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Pericarditis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Ventricular flutter	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Endocrine disorders Hypophysitis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	12.5% 3/24 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Ascites	4.2% 1/24 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Autoimmune colitis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Colitis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Constipation	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Dysphagia	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gastric ulcer	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal haemorrhage	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Incarcerated inguinal hernia	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Nausea	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Vomiting	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Asthenia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Chest pain	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Complication associated with device	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Fatigue	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders General physical health deterioration	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Obstruction	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pain	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pyrexia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Sudden death	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Biliary obstruction	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Cholecystitis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Cholestasis	4.2% 1/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Hepatic cytolysis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Hepatitis	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Anal abscess	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Bacteraemia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Covid-19	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Diarrhoea infectious	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Empyema	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Encephalitis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Fungal skin infection	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Infection	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Influenza	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Liver abscess	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Lower respiratory tract infection	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Meningitis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumocystis jirovecii pneumonia	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia aspiration	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pulmonary sepsis	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Respiratory tract infection	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Sepsis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Urinary tract infection	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.7% 3/28 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Urosepsis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood creatine phosphokinase increased	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood creatinine increased	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations General physical condition abnormal	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Hepatic enzyme increased	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Urine output decreased	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Dehydration	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Malnutrition	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Flank pain	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Aphasia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Bell's palsy	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Cognitive disorder	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Paraneoplastic encephalomyelitis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Spinal cord compression	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Syncope	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Transient ischaemic attack	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Confusional state	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Delirium	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Insomnia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Acute kidney injury	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Dysuria	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Haematuria	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Prerenal failure	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Urinary retention	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleural effusion	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Embolism	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Hypertension	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Other adverse events

Other adverse events
Measure	Cohort A n=24 participants at risk Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort A1 n=26 participants at risk Participants with BTC cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort A2 n=28 participants at risk Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort B n=17 participants at risk Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort C n=27 participants at risk Participants with NSCLC (Second-Fourth L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort D n=24 participants at risk Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.	Cohort E n=26 participants at risk Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Investigations Lymphocyte count decreased	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 8 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Mammogram abnormal	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Occult blood positive	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Gamma-glutamyltransferase increased	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 3/27 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	33.3% 8/24 • Number of events 11 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	26.9% 7/26 • Number of events 9 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	32.1% 9/28 • Number of events 15 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	23.5% 4/17 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	37.0% 10/27 • Number of events 15 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 8/24 • Number of events 10 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 4/26 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Dehydration	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperalbuminaemia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Platelet count decreased	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.8% 4/27 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Weight decreased	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.7% 3/28 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	29.4% 5/17 • Number of events 7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.8% 4/27 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.8% 4/27 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Anaemia	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.9% 5/28 • Number of events 16 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.6% 3/17 • Number of events 15 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	18.5% 5/27 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Neutropenia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 3/26 • Number of events 7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.7% 3/28 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Angina pectoris	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.7% 3/28 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Atrial fibrillation	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 4/28 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Pericardial effusion	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Ear and labyrinth disorders Ear discomfort	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Endocrine disorders Hyperthyroidism	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Endocrine disorders Hypothyroidism	12.5% 3/24 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 4/26 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	29.6% 8/27 • Number of events 11 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Vision blurred	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal distension	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	16.7% 4/24 • Number of events 7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	34.6% 9/26 • Number of events 11 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.9% 5/28 • Number of events 7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	23.5% 4/17 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 3/27 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 4/24 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain upper	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.9% 5/28 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Anal incontinence	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Ascites	4.2% 1/24 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	19.2% 5/26 • Number of events 7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Cheilitis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Colitis	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Constipation	16.7% 4/24 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	23.1% 6/26 • Number of events 7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.9% 5/28 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	29.4% 5/17 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	29.6% 8/27 • Number of events 10 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 4/24 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 4/26 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	16.7% 4/24 • Number of events 8 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	34.6% 9/26 • Number of events 13 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	39.3% 11/28 • Number of events 28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	35.3% 6/17 • Number of events 8 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	29.6% 8/27 • Number of events 20 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	29.2% 7/24 • Number of events 11 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	30.8% 8/26 • Number of events 9 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Dry mouth	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.6% 3/17 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Dyspepsia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Dysphagia	12.5% 3/24 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	21.4% 6/28 • Number of events 10 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.6% 3/17 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gastrooesophageal reflux disease	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gingival bleeding	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gingival pain	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Haematemesis	4.2% 1/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Haematochezia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Malignant gastrointestinal obstruction	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Mucous stools	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Nausea	25.0% 6/24 • Number of events 9 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	42.3% 11/26 • Number of events 12 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	42.9% 12/28 • Number of events 14 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	18.5% 5/27 • Number of events 11 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.8% 5/24 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	30.8% 8/26 • Number of events 11 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Oesophageal pain	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Stomatitis	4.2% 1/24 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	19.2% 5/26 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.9% 5/28 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.8% 4/27 • Number of events 11 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Toothache	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Vomiting	20.8% 5/24 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	19.2% 5/26 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	25.0% 7/28 • Number of events 12 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.8% 4/27 • Number of events 8 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 4/24 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Asthenia	4.2% 1/24 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 4/26 • Number of events 9 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	29.6% 8/27 • Number of events 31 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 4/26 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Chest pain	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 3/27 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Chills	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.7% 3/28 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Complication associated with device	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Face oedema	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Fatigue	58.3% 14/24 • Number of events 21 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	34.6% 9/26 • Number of events 12 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	67.9% 19/28 • Number of events 33 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	52.9% 9/17 • Number of events 15 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	37.0% 10/27 • Number of events 11 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	45.8% 11/24 • Number of events 12 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	34.6% 9/26 • Number of events 15 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Gait disturbance	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders General physical health deterioration	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Influenza like illness	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Localised oedema	8.3% 2/24 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Non-cardiac chest pain	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 3/27 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Oedema peripheral	12.5% 3/24 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	28.6% 8/28 • Number of events 14 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	23.5% 4/17 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.8% 4/27 • Number of events 16 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 3/24 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	19.2% 5/26 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pain	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Peripheral swelling	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 3/24 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pyrexia	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	23.1% 6/26 • Number of events 7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.6% 3/17 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.8% 4/27 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	25.0% 6/24 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Hyperbilirubinaemia	8.3% 2/24 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Bronchitis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Clostridium difficile colitis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Conjunctivitis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Gingivitis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Lip infection	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Lower respiratory tract infection	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Nasopharyngitis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Onychomycosis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Oral candidiasis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Oral fungal infection	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pharyngitis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia aspiration	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Respiratory tract infection	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.8% 4/27 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Rhinitis	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Skin infection	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 3/26 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.7% 3/28 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 3/26 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Urinary tract infection	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.7% 3/28 • Number of events 7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 3/27 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.8% 5/24 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	23.1% 6/26 • Number of events 8 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Fall	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Infusion related reaction	16.7% 4/24 • Number of events 7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 4/26 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Wound complication	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Alanine aminotransferase increased	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	19.2% 5/26 • Number of events 18 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.9% 5/28 • Number of events 11 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.8% 4/27 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 4/24 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 4/26 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Aspartate aminotransferase increased	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 4/26 • Number of events 14 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	21.4% 6/28 • Number of events 12 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	18.5% 5/27 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 4/24 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood alkaline phosphatase increased	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood bilirubin increased	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood cholesterol increased	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood creatine phosphokinase increased	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood creatinine increased	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.7% 3/28 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperglycaemia	12.5% 3/24 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypoalbuminaemia	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 3/24 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.8% 4/27 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 22 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 8 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Malnutrition	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Tetany	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 4/24 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 4/26 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.7% 3/28 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 9/27 • Number of events 19 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 3/26 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.7% 3/28 • Number of events 7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	22.2% 6/27 • Number of events 8 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Bone pain	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Flank pain	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Groin pain	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	12.5% 3/24 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Myalgia	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 4/28 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.8% 4/27 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Dizziness	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 4/28 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.6% 3/17 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Dysgeusia	8.3% 2/24 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Headache	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	19.2% 5/26 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	28.6% 8/28 • Number of events 13 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	18.5% 5/27 • Number of events 9 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.8% 5/24 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 4/26 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Lethargy	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Paraesthesia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Somnolence	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Syncope	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Anxiety	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Insomnia	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.7% 3/28 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 3/27 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Mental status changes	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Dysuria	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Haematuria	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 4/28 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Proteinuria	4.2% 1/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	19.2% 5/26 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	28.6% 8/28 • Number of events 28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.8% 4/27 • Number of events 15 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.8% 5/24 • Number of events 10 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 4/26 • Number of events 9 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Urinary incontinence	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring 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 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Nipple pain	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Scrotal oedema	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	20.8% 5/24 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	26.9% 7/26 • Number of events 8 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 4/28 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.6% 3/17 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	40.7% 11/27 • Number of events 21 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	23.1% 6/26 • Number of events 7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dysphonia	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	18.5% 5/27 • Number of events 6 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	25.0% 6/24 • Number of events 8 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	28.6% 8/28 • Number of events 11 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.6% 3/17 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	29.6% 8/27 • Number of events 11 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	26.9% 7/26 • Number of events 7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 4/28 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	21.4% 6/28 • Number of events 7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	18.5% 5/27 • Number of events 7 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	19.2% 5/26 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Hiccups	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	12.5% 3/24 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.7% 3/28 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 3/27 • Number of events 5 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis psoriasiform	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 3/26 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Erythema	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Pruritus	25.0% 6/24 • Number of events 9 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 3/26 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.8% 4/27 • Number of events 8 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	23.1% 6/26 • Number of events 9 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 2/28 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash maculo-papular	12.5% 3/24 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 3/26 • Number of events 4 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.7% 3/28 • Number of events 8 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 2/17 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	19.2% 5/26 • Number of events 11 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash pruritic	8.3% 2/24 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Deep vein thrombosis	8.3% 2/24 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.7% 3/28 • Number of events 3 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Hypertension	16.7% 4/24 • Number of events 10 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	34.6% 9/26 • Number of events 26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	35.7% 10/28 • Number of events 22 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	23.5% 4/17 • Number of events 8 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 9/27 • Number of events 12 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	29.2% 7/24 • Number of events 9 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	23.1% 6/26 • Number of events 15 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Hypotension	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 1/28 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Vasodilatation	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline Up to 5.9 Years All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60