Trial Outcomes & Findings for A Study of Emibetuzumab in Combination With Ramucirumab (LY3009806) in Participants With Advanced Cancer (NCT NCT02082210)

NCT ID: NCT02082210

Last Updated: 2020-12-19

Results Overview

DLT is defined as an adverse event during Cycle1 that is possibly, probably, or definitely related to treatment with Emibetuzumab in combination with fixed regimen of Ramucirumab \& fulfills any 1 of the following criterion using NCI CTCAE Version 4.03: Grade 3 non-hematological toxicity. Exceptions will be made for:Nausea, vomiting, diarrhea, constipation, or skin rash that persists for ≤3 days following appropriate supportive care intervention. Grade 3 hypertension in which systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg persist \<7 days after intensified antihypertensive therapy is initiated. Grade 4 hematological toxicity of ≥7 days duration. ≥Grade 3 thrombocytopenia with ≥Grade 2 bleeding. Any febrile neutropenia. Any other significant toxicity deemed by the primary investigator \& Lilly clinical research personnel to be dose-limiting (eg, any toxicity that is possibly related to the study medication that requires the withdrawal of participant from study Cycle1).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

97 participants

Primary outcome timeframe

Baseline through Cycle 1 (28 day cycle)

Results posted on

2020-12-19

Participant Flow

Part A: Completers are those who have completed one cycle of treatment. Part B: Completers are those who 1)Have measurable disease at baseline and at least one post-baseline tumor assessment; and 2) Were treated until PD or death, or discontinued due to an AE and completed the required follow-up.

Two part study, Part A with 2 cohorts (750 milligram (mg), 2000mg) \& Part B with four tumor specific cohorts (gastric, hepatocellular carcinoma (HCC), renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC)).

Participant milestones

Participant milestones
Measure	Part A - 750 mg Emibetuzumab Participants received 8 milligram per kilogram (mg/kg) Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part A - 2000 mg Emibetuzumab Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - Gastric Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - HCC Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - RCC Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - NSCLC Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
Overall Study STARTED	3	3	16	45	15	15
Overall Study Received at Least One Dose of Study Drug	3	3	16	45	15	15
Overall Study COMPLETED	3	3	13	39	12	13
Overall Study NOT COMPLETED	0	0	3	6	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Part B - Gastric Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - HCC Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - RCC Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - NSCLC Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
Overall Study Death	1	1	1	0
Overall Study Withdrawal by Subject	0	1	2	2
Overall Study Clinical Progression	0	1	0	0
Overall Study No Post-Baseline Tumor Assesment	1	2	0	0
Overall Study Physician Decision	1	1	0	0

Baseline Characteristics

All participants with baseline ethnicity data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A - 750 mg Emibetuzumab n=3 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part A - 2000 mg Emibetuzumab n=3 Participants Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - Gastric n=16 Participants Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - HCC n=45 Participants Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - RCC n=15 Participants Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - NSCLC n=15 Participants Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Total n=97 Participants Total of all reporting groups
Age, Continuous	41.3 years STANDARD_DEVIATION 20.6 • n=3 Participants	62.0 years STANDARD_DEVIATION 13.5 • n=3 Participants	62.6 years STANDARD_DEVIATION 9.1 • n=16 Participants	63.4 years STANDARD_DEVIATION 9.5 • n=45 Participants	63.1 years STANDARD_DEVIATION 10.1 • n=15 Participants	59.9 years STANDARD_DEVIATION 8.6 • n=15 Participants	62.0 years STANDARD_DEVIATION 10.4 • n=97 Participants
Sex: Female, Male Female	3 Participants n=3 Participants	0 Participants n=3 Participants	4 Participants n=16 Participants	11 Participants n=45 Participants	3 Participants n=15 Participants	6 Participants n=15 Participants	27 Participants n=97 Participants
Sex: Female, Male Male	0 Participants n=3 Participants	3 Participants n=3 Participants	12 Participants n=16 Participants	34 Participants n=45 Participants	12 Participants n=15 Participants	9 Participants n=15 Participants	70 Participants n=97 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=3 Participants • All participants with baseline ethnicity data.	0 Participants n=3 Participants • All participants with baseline ethnicity data.	1 Participants n=16 Participants • All participants with baseline ethnicity data.	3 Participants n=39 Participants • All participants with baseline ethnicity data.	2 Participants n=15 Participants • All participants with baseline ethnicity data.	0 Participants n=14 Participants • All participants with baseline ethnicity data.	6 Participants n=90 Participants • All participants with baseline ethnicity data.
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=3 Participants • All participants with baseline ethnicity data.	3 Participants n=3 Participants • All participants with baseline ethnicity data.	15 Participants n=16 Participants • All participants with baseline ethnicity data.	36 Participants n=39 Participants • All participants with baseline ethnicity data.	13 Participants n=15 Participants • All participants with baseline ethnicity data.	14 Participants n=14 Participants • All participants with baseline ethnicity data.	84 Participants n=90 Participants • All participants with baseline ethnicity data.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants • All participants with baseline ethnicity data.	0 Participants n=3 Participants • All participants with baseline ethnicity data.	0 Participants n=16 Participants • All participants with baseline ethnicity data.	0 Participants n=39 Participants • All participants with baseline ethnicity data.	0 Participants n=15 Participants • All participants with baseline ethnicity data.	0 Participants n=14 Participants • All participants with baseline ethnicity data.	0 Participants n=90 Participants • All participants with baseline ethnicity data.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=3 Participants • All randomized participants with baseline race data.	0 Participants n=3 Participants • All randomized participants with baseline race data.	0 Participants n=15 Participants • All randomized participants with baseline race data.	1 Participants n=43 Participants • All randomized participants with baseline race data.	0 Participants n=14 Participants • All randomized participants with baseline race data.	0 Participants n=14 Participants • All randomized participants with baseline race data.	1 Participants n=92 Participants • All randomized participants with baseline race data.
Race (NIH/OMB) Asian	0 Participants n=3 Participants • All randomized participants with baseline race data.	0 Participants n=3 Participants • All randomized participants with baseline race data.	0 Participants n=15 Participants • All randomized participants with baseline race data.	7 Participants n=43 Participants • All randomized participants with baseline race data.	0 Participants n=14 Participants • All randomized participants with baseline race data.	2 Participants n=14 Participants • All randomized participants with baseline race data.	9 Participants n=92 Participants • All randomized participants with baseline race data.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants • All randomized participants with baseline race data.	0 Participants n=3 Participants • All randomized participants with baseline race data.	0 Participants n=15 Participants • All randomized participants with baseline race data.	0 Participants n=43 Participants • All randomized participants with baseline race data.	0 Participants n=14 Participants • All randomized participants with baseline race data.	0 Participants n=14 Participants • All randomized participants with baseline race data.	0 Participants n=92 Participants • All randomized participants with baseline race data.
Race (NIH/OMB) Black or African American	0 Participants n=3 Participants • All randomized participants with baseline race data.	1 Participants n=3 Participants • All randomized participants with baseline race data.	1 Participants n=15 Participants • All randomized participants with baseline race data.	3 Participants n=43 Participants • All randomized participants with baseline race data.	0 Participants n=14 Participants • All randomized participants with baseline race data.	1 Participants n=14 Participants • All randomized participants with baseline race data.	6 Participants n=92 Participants • All randomized participants with baseline race data.
Race (NIH/OMB) White	3 Participants n=3 Participants • All randomized participants with baseline race data.	2 Participants n=3 Participants • All randomized participants with baseline race data.	14 Participants n=15 Participants • All randomized participants with baseline race data.	32 Participants n=43 Participants • All randomized participants with baseline race data.	14 Participants n=14 Participants • All randomized participants with baseline race data.	11 Participants n=14 Participants • All randomized participants with baseline race data.	76 Participants n=92 Participants • All randomized participants with baseline race data.
Race (NIH/OMB) More than one race	0 Participants n=3 Participants • All randomized participants with baseline race data.	0 Participants n=3 Participants • All randomized participants with baseline race data.	0 Participants n=15 Participants • All randomized participants with baseline race data.	0 Participants n=43 Participants • All randomized participants with baseline race data.	0 Participants n=14 Participants • All randomized participants with baseline race data.	0 Participants n=14 Participants • All randomized participants with baseline race data.	0 Participants n=92 Participants • All randomized participants with baseline race data.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants • All randomized participants with baseline race data.	0 Participants n=3 Participants • All randomized participants with baseline race data.	0 Participants n=15 Participants • All randomized participants with baseline race data.	0 Participants n=43 Participants • All randomized participants with baseline race data.	0 Participants n=14 Participants • All randomized participants with baseline race data.	0 Participants n=14 Participants • All randomized participants with baseline race data.	0 Participants n=92 Participants • All randomized participants with baseline race data.
Region of Enrollment United States	3 Participants n=3 Participants	3 Participants n=3 Participants	16 Participants n=16 Participants	45 Participants n=45 Participants	15 Participants n=15 Participants	15 Participants n=15 Participants	97 Participants n=97 Participants

PRIMARY outcome

Timeframe: Baseline through Cycle 1 (28 day cycle)

Population: All participants who received at least one dose of Emibetuzumab in Part A \& Part B.

Outcome measures

Outcome measures
Measure	Part A - 750 mg Emibetuzumab n=3 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part A - 2000 mg Emibetuzumab n=3 Participants Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - Gastric n=16 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - HCC n=45 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - RCC n=15 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - NSCLC n=15 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline through Measured Progressive Disease or Death (Up to 17 months)

Population: All participants who received at least one dose of Emibetuzumab in Part B.

ORR is the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. 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 5mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

Outcome measures

Outcome measures
Measure	Part A - 750 mg Emibetuzumab n=16 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part A - 2000 mg Emibetuzumab n=45 Participants Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - Gastric n=15 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - HCC n=15 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - RCC Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - NSCLC Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
Part B: Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]	6.3 percentage of participants Interval 0.0 to 30.0	6.7 percentage of participants Interval 0.0 to 20.0	0 percentage of participants Interval 0.0 to 20.0	6.7 percentage of participants Interval 0.0 to 30.0	—	—

SECONDARY outcome

Timeframe: Cycle 1: Day1 Predose, End of infusion, 3 Hours (h), 5h, 8h, 21h, 168h, 334h, 335h and 336h Post dose

Population: All participants who received at least one dose of Emibetuzumab and had evaluable PK samples in Part A \& Part B. Per protocol analysis was performed per each dose irrespective of the study parts.

Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Emibetuzumab.

Outcome measures

Outcome measures
Measure	Part A - 750 mg Emibetuzumab n=24 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part A - 2000 mg Emibetuzumab n=3 Participants Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - Gastric Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - HCC Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - RCC Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - NSCLC Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Emibetuzumab	210 Microgram per milliliter (µg/mL) Geometric Coefficient of Variation 27	575 Microgram per milliliter (µg/mL) Geometric Coefficient of Variation 33	—	—	—	—

SECONDARY outcome

Timeframe: Baseline through Measured Progressive Disease (Up to 17 months)

Population: All participants who received at least one dose of Emibetuzumab in Part B.

DCR is the proportion of participants who exhibit a SD or confirmed CR or PR relative to baseline. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. 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 5mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

Outcome measures

Outcome measures
Measure	Part A - 750 mg Emibetuzumab n=16 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part A - 2000 mg Emibetuzumab n=45 Participants Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - Gastric n=15 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - HCC n=15 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - RCC Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - NSCLC Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
Part B: Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR) (Disease Control Rate [DCR])	50 percentage of participants Interval 20.0 to 80.0	60 percentage of participants Interval 40.0 to 70.0	46.7 percentage of participants Interval 20.0 to 70.0	86.7 percentage of participants Interval 60.0 to 100.0	—	—

SECONDARY outcome

Timeframe: Baseline to Measured Progressive Disease or Death (Up to 17 Months)

Population: All participants who received at least one dose of Emibetuzumab in part B. Censored participants in Part B- Gastric = 4; Part B - HCC = 15; Part B - RCC = 7; Part - B NSCLC = 4;

PFS was defined as the time from the date of first dose of study drug until first observation of objective (radiographically documented) PD as defined by RECIST v1.1 or death from any cause, whichever comes first. 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	Part A - 750 mg Emibetuzumab n=16 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part A - 2000 mg Emibetuzumab n=45 Participants Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - Gastric n=15 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - HCC n=15 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - RCC Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - NSCLC Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
Part B: Progression Free Survival (PFS)	1.64 months Interval 1.35 to 4.6	5.42 months Interval 1.64 to 8.12	2.92 months Interval 1.18 to 7.39	6.57 months Interval 2.86 to 9.66	—	—

SECONDARY outcome

Timeframe: Cycle 1: Day1 Predose, End of infusion, 3 Hours (h), 5h, 8h, 21h, 168h, 334h, 335h and 336h Post dose

Population: All participants who received at least one dose of Emibetuzumab and had evaluable PK samples in Part A \& Part B. Per protocol, analysis was performed per each dose irrespective of study parts.

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) from time zero to tlast of Emibetuzumab.

Outcome measures

Outcome measures
Measure	Part A - 750 mg Emibetuzumab n=24 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part A - 2000 mg Emibetuzumab n=3 Participants Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - Gastric Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - HCC Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - RCC Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - NSCLC Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) From Time Zero to Tlast of Emibetuzumab	29800 Microgram * hour per milliliter(µg*h/mL) Geometric Coefficient of Variation 26	86500 Microgram * hour per milliliter(µg*h/mL) Geometric Coefficient of Variation 25	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: Day1 Predose, End of infusion, 3 Hours (h), 5h, 8h, 21h, 168h and 336h Post dose

Population: Noncompartmental PK parameters were not generated for Ramucirumab due to inadequate PK sampling.

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Ramucirumab.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through 46 Months

Population: All participants who received at least one dose of Emibetuzumab and had evaluable immunogenicity samples.

Participants were considered as treatment-emergent anti drug antibodies (TE ADA) positive if there is a ≥4-fold increase from baseline when ADAs were detected at baseline. If no ADAs were detected at baseline, TE ADA were defined as those with a titer 2 fold (1 dilution) greater than the minimum required dilution (MRD) of the screening assay (1:4 for anti-emibetuzumab antibodies).

Outcome measures

Outcome measures
Measure	Part A - 750 mg Emibetuzumab n=3 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part A - 2000 mg Emibetuzumab n=3 Participants Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - Gastric n=15 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - HCC n=42 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - RCC n=15 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - NSCLC n=15 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
Number of Participants With Treatment Emergent Anti-Emibetuzumab Antibodies	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Cycle 1: Day1 Predose, End of infusion, 3 Hours (h), 5h, 8h, 21h, 168h and 336h Post dose

Population: Noncompartmental PK parameters were not generated for Ramucirumab due to inadequate PK sampling.

Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Ramucirumab.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through 46 Months

Population: All participants who received at least one dose of ramucirumab and had evaluable immunogenicity samples.

Outcome measures

Outcome measures
Measure	Part A - 750 mg Emibetuzumab n=3 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part A - 2000 mg Emibetuzumab n=3 Participants Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - Gastric n=16 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - HCC n=44 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - RCC n=15 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - NSCLC n=15 Participants Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
Number of Participants With Treatment Emergent Anti-Ramucirumab Antibodies	1 Participants	0 Participants	0 Participants	4 Participants	1 Participants	0 Participants

Adverse Events

Part A - 750 mg Emibetuzumab

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A - 2000 mg Emibetuzumab

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Part B - Gastric

Serious events: 4 serious events

Other events: 15 other events

Deaths: 3 deaths

Part B - HCC

Serious events: 19 serious events

Other events: 45 other events

Deaths: 4 deaths

Part B - RCC

Serious events: 5 serious events

Other events: 15 other events

Deaths: 1 deaths

Part B - NSCLC

Serious events: 3 serious events

Other events: 14 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Part A - 750 mg Emibetuzumab n=3 participants at risk Participants received 8 milligram per kilogram (mg/kg) Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part A - 2000 mg Emibetuzumab n=3 participants at risk Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - Gastric n=16 participants at risk Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - HCC n=45 participants at risk Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - RCC n=15 participants at risk Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - NSCLC n=15 participants at risk Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Pericardial effusion	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Ascites	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Constipation	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gastritis	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Oesophagitis	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Oedema peripheral	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pain	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pyrexia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Cholecystitis	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Clostridium difficile infection	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Endocarditis	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Enterocolitis infectious	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Influenza	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Lung infection	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Hepatic encephalopathy	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Mental status changes	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Hypotension	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.

Other adverse events

Other adverse events
Measure	Part A - 750 mg Emibetuzumab n=3 participants at risk Participants received 8 milligram per kilogram (mg/kg) Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part A - 2000 mg Emibetuzumab n=3 participants at risk Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - Gastric n=16 participants at risk Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - HCC n=45 participants at risk Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - RCC n=15 participants at risk Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.	Part B - NSCLC n=15 participants at risk Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	18.8% 3/16 • Number of events 6 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	24.4% 11/45 • Number of events 12 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	26.7% 4/15 • Number of events 4 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gingival bleeding	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Eye discharge	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Lacrimation increased	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Periorbital oedema	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Vision blurred	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 6/45 • Number of events 8 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Ascites	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 9/45 • Number of events 11 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Constipation	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	31.2% 5/16 • Number of events 6 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	26.7% 12/45 • Number of events 14 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 3/15 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 5/15 • Number of events 6 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	18.8% 3/16 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	24.4% 11/45 • Number of events 12 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	26.7% 4/15 • Number of events 6 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	18.8% 3/16 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gingival swelling	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Haematemesis	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Lip dry	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	50.0% 8/16 • Number of events 15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	26.7% 12/45 • Number of events 16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	26.7% 4/15 • Number of events 5 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	26.7% 4/15 • Number of events 6 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Proctalgia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Retching	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 3/15 • Number of events 4 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Toothache	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	37.5% 6/16 • Number of events 11 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	15.6% 7/45 • Number of events 8 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 5/15 • Number of events 7 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Asthenia	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	31.2% 5/16 • Number of events 5 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 4 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Breakthrough pain	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Endocrine disorders Hyperthyroidism	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Endocrine disorders Hypothyroidism	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	31.2% 5/16 • Number of events 5 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	15.6% 7/45 • Number of events 9 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 6 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Thrombocytopenia	33.3% 1/3 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	15.6% 7/45 • Number of events 9 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Palpitations	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Sinus bradycardia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Tachycardia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Chills	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.9% 4/45 • Number of events 4 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Fatigue	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	68.8% 11/16 • Number of events 20 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	55.6% 25/45 • Number of events 34 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	40.0% 6/15 • Number of events 7 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	60.0% 9/15 • Number of events 13 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Gait disturbance	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Malaise	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Non-cardiac chest pain	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.9% 4/45 • Number of events 4 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Oedema	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 4 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Oedema peripheral	100.0% 3/3 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	37.5% 6/16 • Number of events 15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	57.8% 26/45 • Number of events 38 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 5/15 • Number of events 9 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 5/15 • Number of events 9 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pain	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pyrexia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Swelling	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 5 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Rubber sensitivity	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Seasonal allergy	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Conjunctivitis	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Infected cyst	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Lung infection	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Mucosal infection	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Oral candidiasis	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Rash pustular	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Sinusitis	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Tooth abscess	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Tooth infection	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Urinary tract infection	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.9% 4/45 • Number of events 4 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Wound	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	25.0% 4/16 • Number of events 5 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 5/45 • Number of events 5 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 6/45 • Number of events 7 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood albumin decreased	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 4 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 5 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 5/45 • Number of events 5 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood bilirubin increased	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 7 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood calcium decreased	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood creatinine increased	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood glucose increased	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Haemoglobin decreased	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations International normalised ratio increased	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.9% 4/45 • Number of events 6 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Paracentesis	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Platelet count decreased	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 5/45 • Number of events 7 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Weight decreased	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 3/15 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations White blood cell count decreased	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 8 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	66.7% 2/3 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	50.0% 8/16 • Number of events 8 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	24.4% 11/45 • Number of events 13 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 3/15 • Number of events 4 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 3/15 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 6/45 • Number of events 11 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 4 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	18.8% 3/16 • Number of events 5 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	28.9% 13/45 • Number of events 21 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	15.6% 7/45 • Number of events 11 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 6 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	18.8% 3/16 • Number of events 5 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 9/45 • Number of events 15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.9% 4/45 • Number of events 4 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.9% 4/45 • Number of events 4 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 3/15 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 3/15 • Number of events 5 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 5/45 • Number of events 5 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 3/15 • Number of events 4 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.9% 4/45 • Number of events 4 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	18.8% 3/16 • Number of events 4 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Dizziness	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 4 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Dysgeusia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Headache	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	31.2% 5/16 • Number of events 5 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	26.7% 4/15 • Number of events 5 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	26.7% 4/15 • Number of events 4 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Memory impairment	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Paraesthesia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Presyncope	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Sciatica	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Confusional state	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Depression	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Hallucination	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Insomnia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Mental status changes	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Dysuria	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Haematuria	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Micturition urgency	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Nocturia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Proteinuria	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Urinary retention	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Urinary tract pain	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Breast mass	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 1/9 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Menorrhagia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Penile oedema	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/9 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Scrotal oedema	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/9 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 5 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	26.7% 12/45 • Number of events 21 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	53.3% 8/15 • Number of events 9 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Haemoptysis	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	15.6% 7/45 • Number of events 7 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleural effusion	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Wheezing	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 5/45 • Number of events 5 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Purpura	33.3% 1/3 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Embolism	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Hypertension	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	24.4% 11/45 • Number of events 30 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Hypotension	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Jugular vein thrombosis	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Lymphoedema	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Thrombophlebitis superficial	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Venous thrombosis	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Up to 46 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release \& can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to sponsor for review. Sponsor can extend disclosure restriction for additional 60 days to protect intellectual property interests. If PI is unwilling to delay then PI shall remove the information that sponsor believes would jeopardize its IP interests
Publication restrictions are in place

Restriction type: OTHER