Trial Outcomes & Findings for Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN (NCT NCT03386513)

Last Updated: 2026-09-04

Results Overview

CCR rate was defined as percentage of participants with complete remission/response (CR) and clinical complete remission (CRc). CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/microliter \[μL\]) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on computed tomography (CT); and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

179 participants

Primary outcome timeframe

Up to approximately 81 months

Results posted on

2026-09-04

Participant Flow

The study is ongoing and reports data up to the primary analysis data cut-off date (up to approximately 81 months).

Participant milestones

Participant milestones
Measure	Dose Escalation - Schedule A: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 milligrams (mg)/kilogram (kg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.045 mg/kg Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.09 mg/kg Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.18 mg/kg Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.3 mg/kg Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.45 mg/kg Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Expansion - Schedule A: IMGN632 0.045 mg/kg Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Expansion - Schedule A: IMGN632 0.09 mg/kg Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Overall Study STARTED	3	12	13	7	5	2	3	6	14	104	10
Overall Study Received at least 1 dose of study drug	3	12	13	7	5	2	3	6	14	104	10
Overall Study COMPLETED	0	1	1	0	0	0	0	0	0	8	0
Overall Study NOT COMPLETED	3	11	12	7	5	2	3	6	14	96	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Escalation - Schedule A: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 milligrams (mg)/kilogram (kg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.045 mg/kg Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.09 mg/kg Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.18 mg/kg Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.3 mg/kg Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.45 mg/kg Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Expansion - Schedule A: IMGN632 0.045 mg/kg Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Expansion - Schedule A: IMGN632 0.09 mg/kg Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Overall Study Withdrawal by Subject	1	0	0	0	0	0	0	0	1	2	1
Overall Study Lost to Follow-up	0	0	0	0	0	0	0	0	0	3	0
Overall Study Sponsor Decision	0	1	0	0	0	0	0	0	1	0	0
Overall Study Investigator Decision	0	0	0	0	0	0	0	0	0	1	0
Overall Study Death	2	10	12	7	5	2	3	6	12	76	9
Overall Study Other than Specified	0	0	0	0	0	0	0	0	0	1	0
Overall Study Ongoing in Trial at Time of Data Cutoff	0	0	0	0	0	0	0	0	0	13	0

Baseline Characteristics

Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Escalation - Schedule A: IMGN632 0.015 mg/kg n=3 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.045 mg/kg n=12 Participants Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.09 mg/kg n=13 Participants Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.18 mg/kg n=7 Participants Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.3 mg/kg n=5 Participants Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.45 mg/kg n=2 Participants Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg n=3 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg n=6 Participants Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg n=14 Participants Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Expansion - Schedule A: IMGN632 0.045 mg/kg n=104 Participants Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Expansion - Schedule A: IMGN632 0.09 mg/kg n=10 Participants Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Total n=179 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=113 Participants	0 Participants n=912 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=23 Participants	2 Participants n=23 Participants	8 Participants n=22 Participants	4 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=113 Participants	1 Participants n=912 Participants	0 Participants n=3 Participants	4 Participants n=4 Participants	34 Participants n=4 Participants	4 Participants n=4 Participants	58 Participants n=36 Participants
Age, Categorical >=65 years	2 Participants n=23 Participants	10 Participants n=23 Participants	5 Participants n=22 Participants	3 Participants n=21 Participants	5 Participants n=24 Participants	2 Participants n=113 Participants	2 Participants n=912 Participants	6 Participants n=3 Participants	10 Participants n=4 Participants	70 Participants n=4 Participants	6 Participants n=4 Participants	121 Participants n=36 Participants
Sex: Female, Male Female	2 Participants n=23 Participants	8 Participants n=23 Participants	8 Participants n=22 Participants	3 Participants n=21 Participants	2 Participants n=24 Participants	1 Participants n=113 Participants	1 Participants n=912 Participants	4 Participants n=3 Participants	3 Participants n=4 Participants	17 Participants n=4 Participants	4 Participants n=4 Participants	53 Participants n=36 Participants
Sex: Female, Male Male	1 Participants n=23 Participants	4 Participants n=23 Participants	5 Participants n=22 Participants	4 Participants n=21 Participants	3 Participants n=24 Participants	1 Participants n=113 Participants	2 Participants n=912 Participants	2 Participants n=3 Participants	11 Participants n=4 Participants	87 Participants n=4 Participants	6 Participants n=4 Participants	126 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=23 Participants	2 Participants n=23 Participants	1 Participants n=22 Participants	1 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=113 Participants	0 Participants n=912 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	13 Participants n=4 Participants	2 Participants n=4 Participants	19 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=23 Participants	9 Participants n=23 Participants	12 Participants n=22 Participants	6 Participants n=21 Participants	5 Participants n=24 Participants	2 Participants n=113 Participants	2 Participants n=912 Participants	5 Participants n=3 Participants	14 Participants n=4 Participants	85 Participants n=4 Participants	8 Participants n=4 Participants	151 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=23 Participants	1 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=113 Participants	1 Participants n=912 Participants	1 Participants n=3 Participants	0 Participants n=4 Participants	6 Participants n=4 Participants	0 Participants n=4 Participants	9 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=113 Participants	0 Participants n=912 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=113 Participants	0 Participants n=912 Participants	1 Participants n=3 Participants	0 Participants n=4 Participants	1 Participants n=4 Participants	0 Participants n=4 Participants	2 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=113 Participants	0 Participants n=912 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	1 Participants n=23 Participants	0 Participants n=23 Participants	3 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=113 Participants	0 Participants n=912 Participants	0 Participants n=3 Participants	1 Participants n=4 Participants	4 Participants n=4 Participants	1 Participants n=4 Participants	10 Participants n=36 Participants
Race (NIH/OMB) White	2 Participants n=23 Participants	12 Participants n=23 Participants	10 Participants n=22 Participants	7 Participants n=21 Participants	5 Participants n=24 Participants	2 Participants n=113 Participants	3 Participants n=912 Participants	5 Participants n=3 Participants	13 Participants n=4 Participants	86 Participants n=4 Participants	9 Participants n=4 Participants	154 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=113 Participants	0 Participants n=912 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=113 Participants	0 Participants n=912 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	13 Participants n=4 Participants	0 Participants n=4 Participants	13 Participants n=36 Participants

PRIMARY outcome

Timeframe: Up to approximately 81 months

Population: Modified Intent-to-treat (mITT) Population included all participants who were eligible based on the screening criteria and who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = Frontline de novo BPDCN participants. Per protocol, this endpoint evaluated only Frontline De Novo BPDCN Participants, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=22 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Composite Complete Remission/Response (CCR) Rate As Assessed by Investigator in Frontline De Novo Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Participants	—	—	—	—	—	—	72.7 percentage of participants Interval 49.78 to 89.27	—	—

SECONDARY outcome

Timeframe: Up to approximately 81 months

Population: The safety population included all participants who received at least 1 dose of study drug.

An adverse event (AE) was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. This included an exacerbation of a pre-existing condition. SAEs included death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any new AEs that begin or any pre-existing conditions that worsen in severity from the first dose of study drug through 30 days after the last dose or prior to the subsequent therapy, whichever occurs first.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg n=2 Participants Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg n=7 Participants Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg n=5 Participants Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg n=3 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg n=6 Participants Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg n=14 Participants Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=3 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg n=12 Participants Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg n=13 Participants Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) All TEAEs	2 Participants	7 Participants	5 Participants	3 Participants	6 Participants	14 Participants	3 Participants	12 Participants	13 Participants
Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	2 Participants	7 Participants	5 Participants	2 Participants	6 Participants	11 Participants	2 Participants	7 Participants	11 Participants

SECONDARY outcome

Timeframe: Up to approximately 81 months

Population: The safety population included all participants who received at least 1 dose of study drug.

DLT was defined as all treatment-emergent adverse events (TEAEs) or abnormal laboratory values that met the protocol-defined DLT criteria, including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg n=2 Participants Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg n=7 Participants Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg n=5 Participants Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg n=3 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg n=6 Participants Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg n=14 Participants Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=3 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg n=12 Participants Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg n=13 Participants Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs)	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3 (each cycle length = 21 days)

Population: Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of study drug and from whom results of concentration had been obtained at least 1 sampling point. PK data were collected and analyses were conducted in participants per treatment schedule and dose in both phases (dose escalation and expansion) combined. Here, 'number analyzed' = participants evaluable for specified categories.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg n=2 Participants Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg n=7 Participants Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg n=5 Participants Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg n=2 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg n=6 Participants Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg n=13 Participants Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=2 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg n=107 Participants Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg n=23 Participants Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Maximum Plasma Concentration (Cmax) of IMGN632 (Antibody Drug Conjugate [ADC]) and Total Antibody Total Antibody: Cycle 3	—	—	—	0.167 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation NA Geometric Coefficient of Variation not calculable with n=1	0.457 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 28	—	—	0.607 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 81	2.03 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 146
Maximum Plasma Concentration (Cmax) of IMGN632 (Antibody Drug Conjugate [ADC]) and Total Antibody IMGN632 ADC: Cycle 1	8.44 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 21	2.69 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 26	4.64 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 42	0.0247 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 72	0.396 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 234	0.405 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 120	0.0291 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 669	0.442 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 122	1.08 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 68
Maximum Plasma Concentration (Cmax) of IMGN632 (Antibody Drug Conjugate [ADC]) and Total Antibody Total Antibody: Cycle 1	7.36 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 21	2.79 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 37	4.87 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 45	—	0.439 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 256	0.415 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 108	0.160 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation NA Geometric Coefficient of Variation not calculable with n=1	0.611 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 143	0.978 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 105
Maximum Plasma Concentration (Cmax) of IMGN632 (Antibody Drug Conjugate [ADC]) and Total Antibody IMGN632 ADC: Cycle 3	—	—	—	0.0291 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 1831	0.480 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 43	—	0.0789 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation NA Geometric Coefficient of Variation not calculable with n=1	0.564 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 105	2.08 micrograms (µg)/milliliter (mL) Geometric Coefficient of Variation 127

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3 (each cycle length = 21 days)

Population: PK analysis set included all participants who received at least 1 dose of study drug and from whom results of concentration had been obtained at least 1 sampling point. PK data were collected and analyses were conducted in participants per treatment schedule and dose in both phases (dose escalation and expansion) combined. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg n=2 Participants Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg n=7 Participants Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg n=5 Participants Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg n=3 Participants Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg n=12 Participants Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg n=87 Participants Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg n=22 Participants Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Cmax of FGN849 Cycle 1	102 picograms (pg)/mL Geometric Coefficient of Variation 70	65.4 picograms (pg)/mL Geometric Coefficient of Variation 25	152 picograms (pg)/mL Geometric Coefficient of Variation 67	—	36.0 picograms (pg)/mL Geometric Coefficient of Variation 33	55.7 picograms (pg)/mL Geometric Coefficient of Variation 90	—	58.8 picograms (pg)/mL Geometric Coefficient of Variation 77	79.7 picograms (pg)/mL Geometric Coefficient of Variation 80
Cmax of FGN849 Cycle 3	—	—	—	—	27.1 picograms (pg)/mL Geometric Coefficient of Variation 37	—	—	43.7 picograms (pg)/mL Geometric Coefficient of Variation 55	28.7 picograms (pg)/mL Geometric Coefficient of Variation 51

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3 (each cycle length = 21 days)

Population: The PK analysis set included all participants who received at least 1 dose of study drug and from whom results of concentration had been obtained at least 1 sampling point. PK data were collected and analyses were conducted in participants per treatment schedule and dose in both phases (dose escalation and expansion) combined. Here, 'number analyzed' = participants evaluable for specified categories.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg n=2 Participants Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg n=7 Participants Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg n=5 Participants Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg n=2 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg n=6 Participants Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg n=13 Participants Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=2 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg n=107 Participants Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg n=23 Participants Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of IMGN632 (ADC) and Total Antibody IMGN632 ADC: Cycle 1	113 hours*µg/mL Geometric Coefficient of Variation 42	24.7 hours*µg/mL Geometric Coefficient of Variation 44	46.7 hours*µg/mL Geometric Coefficient of Variation 66	0.0227 hours*µg/mL Geometric Coefficient of Variation 31	0.792 hours*µg/mL Geometric Coefficient of Variation 248	1.11 hours*µg/mL Geometric Coefficient of Variation 269	0.0471 hours*µg/mL Geometric Coefficient of Variation 825	0.892 hours*µg/mL Geometric Coefficient of Variation 223	4.12 hours*µg/mL Geometric Coefficient of Variation 140
Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of IMGN632 (ADC) and Total Antibody Total Antibody: Cycle 1	123 hours*µg/mL Geometric Coefficient of Variation 50	31.0 hours*µg/mL Geometric Coefficient of Variation 66	51.8 hours*µg/mL Geometric Coefficient of Variation 68	—	0.708 hours*µg/mL Geometric Coefficient of Variation 355	1.02 hours*µg/mL Geometric Coefficient of Variation 371	0.152 hours*µg/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation not calculable with n=1	0.939 hours*µg/mL Geometric Coefficient of Variation 241	3.50 hours*µg/mL Geometric Coefficient of Variation 254
Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of IMGN632 (ADC) and Total Antibody IMGN632 ADC: Cycle 3	—	—	—	0.0145 hours*µg/mL Geometric Coefficient of Variation 1831	1.25 hours*µg/mL Geometric Coefficient of Variation 185	—	0.202 hours*µg/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation not calculable with n=1	1.61 hours*µg/mL Geometric Coefficient of Variation 191	12.1 hours*µg/mL Geometric Coefficient of Variation 56
Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of IMGN632 (ADC) and Total Antibody Total Antibody: Cycle 3	—	—	—	0.0835 hours*µg/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation not calculable with n=1	1.05 hours*µg/mL Geometric Coefficient of Variation 121	—	—	1.41 hours*µg/mL Geometric Coefficient of Variation 124	15.4 hours*µg/mL Geometric Coefficient of Variation 111

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3 (each cycle length = 21 days)

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg n=2 Participants Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg n=7 Participants Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg n=5 Participants Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg n=3 Participants Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg n=12 Participants Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg n=87 Participants Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg n=22 Participants Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
AUC0-last of FGN849 Cycle 1	1139 hours*pg/mL Geometric Coefficient of Variation 29	248 hours*pg/mL Geometric Coefficient of Variation 41	1260 hours*pg/mL Geometric Coefficient of Variation 73	—	63.5 hours*pg/mL Geometric Coefficient of Variation 158	177 hours*pg/mL Geometric Coefficient of Variation 169	—	171 hours*pg/mL Geometric Coefficient of Variation 116	354 hours*pg/mL Geometric Coefficient of Variation 99
AUC0-last of FGN849 Cycle 3	—	—	—	—	66.1 hours*pg/mL Geometric Coefficient of Variation 144	—	—	125 hours*pg/mL Geometric Coefficient of Variation 105	59.6 hours*pg/mL Geometric Coefficient of Variation 1541

SECONDARY outcome

Timeframe: Up to approximately 81 months

Population: The safety population included all participants who received at least 1 dose of study drug. ADA data were collected and reported per treatment schedule and dose in both phases (dose escalation and expansion) combined. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg n=2 Participants Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg n=7 Participants Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg n=4 Participants Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg n=3 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg n=6 Participants Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg n=10 Participants Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=3 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg n=111 Participants Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg n=19 Participants Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Number of Participants With Anti-drug Antibodies (ADAs) at Any Post-baseline Visit	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	22 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to approximately 81 months

ORR was defined as percentage of participants with CR without minimal residual disease (CRMRD-), CR, CR with partial hematologic recovery (CRh), CR with incomplete recovery (CRi), morphologic leukemia-free state (MLFS), or partial response (PR). CRMRD-: CR with negativity for a genetic marker. CR: Morphologic CR \<5% blasts; Absolute neutrophil count (ANC) \>1000/μL; Platelets ≥100,000/μL; Participant independent of transfusions; No residual evidence of active extramedullary disease; MRD+ or unknown. CRh: Met requirements for CR except ANC \>500/μL and platelets \>50,000/μL. CRi: Met requirements for CR except either ANC \<1000/μL or platelets \<100,000/μL. MLFS: Bone marrow \<5% blasts in an aspirate with spicules; No blasts with Auer rods or persistence of extramedullary disease; Marrow not "aplastic"; ≥200 cells should be enumerated or cellularity should be ≥10%. PR: Decrease of ≥50% in percentage of blasts to 5% to 25% in bone marrow aspirate (BMA) and normalization of blood counts.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg n=2 Participants Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg n=7 Participants Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg n=5 Participants Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg n=3 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg n=6 Participants Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg n=14 Participants Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=3 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg n=9 Participants Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg n=12 Participants Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Dose Escalation Phase: Overall Response Rate (ORR), As Assessed by Investigator in Participants With AML	0 percentage of participants Interval 0.0 to 84.19	14.3 percentage of participants Interval 0.36 to 57.87	20.0 percentage of participants Interval 0.51 to 71.64	0 percentage of participants Interval 0.0 to 70.76	16.7 percentage of participants Interval 0.42 to 64.12	7.1 percentage of participants Interval 0.18 to 33.87	33.3 percentage of participants Interval 0.84 to 90.57	22.2 percentage of participants Interval 2.81 to 60.01	8.3 percentage of participants Interval 0.21 to 38.48

SECONDARY outcome

Timeframe: Up to approximately 81 months

CR+CRh rate was defined as percentage of participants with CR, and CRh. CR: Morphologic CR \<5% blasts; Absolute neutrophil count (ANC) \>1000/μL; Platelets ≥100,000/μL; Participant independent of transfusions; No residual evidence of active extramedullary disease; MRD+ or unknown. CRh: Met requirements for CR except ANC \>500/μL and platelets \>50,000/μL.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg n=2 Participants Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg n=7 Participants Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg n=5 Participants Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg n=3 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg n=6 Participants Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg n=14 Participants Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=3 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg n=9 Participants Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg n=12 Participants Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Dose Escalation Phase: CR+CRh Rate, As Assessed by Investigator in Participants With AML	0 percentage of participants Interval 0.0 to 84.19	14.3 percentage of participants Interval 0.36 to 57.87	0 percentage of participants Interval 0.0 to 52.18	0 percentage of participants Interval 0.0 to 70.76	0 percentage of participants Interval 0.0 to 45.93	0 percentage of participants Interval 0.0 to 23.16	33.3 percentage of participants Interval 0.84 to 90.57	11.1 percentage of participants Interval 0.28 to 48.25	0 percentage of participants Interval 0.0 to 26.46

SECONDARY outcome

Timeframe: Up to approximately 81 months

CR+CRh+CRi rate was defined as percentage of participants with CR, CRh, or CRi. CR: Morphologic CR \<5% blasts; Absolute neutrophil count (ANC) \>1000/μL; Platelets ≥100,000/μL; Participant independent of transfusions; No residual evidence of active extramedullary disease; MRD+ or unknown. CRh: Met requirements for CR except ANC \>500/μL and platelets \>50,000/μL. CRi: Met requirements for CR except either ANC \<1000/μL or platelets \<100,000/μL.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg n=2 Participants Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg n=7 Participants Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg n=5 Participants Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg n=3 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg n=6 Participants Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg n=14 Participants Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=3 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg n=9 Participants Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg n=12 Participants Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Dose Escalation Phase: CR+CRh+CRi Rate, As Assessed by Investigator in Participants With AML	0 percentage of participants Interval 0.0 to 84.19	14.3 percentage of participants Interval 0.36 to 57.87	20.0 percentage of participants Interval 0.51 to 71.64	0 percentage of participants Interval 0.0 to 70.76	16.7 percentage of participants Interval 0.42 to 64.12	7.1 percentage of participants Interval 0.18 to 33.87	33.3 percentage of participants Interval 0.84 to 90.57	11.1 percentage of participants Interval 0.28 to 48.25	0 percentage of participants Interval 0.0 to 26.46

SECONDARY outcome

Timeframe: Up to approximately 81 months

Population: mITT Population included all participants who were eligible based on the screening criteria and who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = R/R BPDCN participants. Per protocol, this endpoint evaluated only R/R BPDCN Participants, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.

CCR rate was defined as percentage of participants with CR and CRc. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=51 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
CCR Rate As Assessed by Investigator in Participants With Relapsed/Refractory (R/R) BPDCN	—	—	—	—	—	—	13.7 percentage of participants Interval 5.7 to 26.26	—	—

SECONDARY outcome

Timeframe: Up to approximately 81 months

Population: mITT Population included all participants who were eligible based on the screening criteria and who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = Frontline de novo BPDCN participants with CR or CRc. Per protocol, this endpoint evaluated only Frontline de novo BPDCN participants with CR or CRc, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.

DOCR was defined from the first response (CR or CRc) to the time of relapse or death from any cause, whichever came first. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. Median and 95% CI were calculated by Kaplan-Meier estimation.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=9 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Duration of CCR (DOCR) As Assessed by Investigator in Frontline De Novo BPDCN Participants With CR or CRc	—	—	—	—	—	—	10.18 months Interval 4.402 to Data could not be calculated due to insufficient number of events.	—	—

SECONDARY outcome

Timeframe: Up to approximately 81 months

Population: mITT Population included all participants who were eligible based on the screening criteria and who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = R/R BPDCN participants with CR or CRc. Per protocol, this endpoint evaluated only R/R BPDCN participants with CR or CRc, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.

DOCR was defined from the first response (CR or CRc) to the time of relapse or death from any cause, whichever comes first. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=4 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
DOCR As Assessed by Investigator in R/R BPDCN Participants With CR or CRc	—	—	—	—	—	—	9.20 months Interval 2.398 to Data could not be calculated due to insufficient number of events.	—	—

SECONDARY outcome

Timeframe: Up to approximately 81 months

Population: mITT Population included all participants who were eligible based on the screening criteria and who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = Total frontline BPDCN participants with CR or CRc. Per protocol, this endpoint evaluated only total frontline BPDCN participants with CR or CRc, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=15 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
DOCR As Assessed by Investigator in Total Frontline BPDCN Participants With CR or CRc	—	—	—	—	—	—	9.76 months Interval 4.632 to Data could not be calculated due to insufficient number of events.	—	—

SECONDARY outcome

Timeframe: Up to approximately 81 months

Population: The safety population included all participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = participants treated with IMGN632 at the RP2D.

An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. This included an exacerbation of a pre-existing condition. TEAEs were defined as any new AEs that began or any pre-existing conditions that worsen in severity from the first dose of study drug through 30 days after the last dose or prior to the subsequent therapy, whichever occurs first.. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=116 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Number of Participants With TEAEs in Participants Who Received IMGN632 As a Single Agent at the RP2D Level (0.045 mg/kg)	—	—	—	—	—	—	115 Participants	—	—

SECONDARY outcome

Timeframe: Up to approximately 81 months

Rate of CR+CRc+CRh: percentage of participants with CR, CRc, and CRh. CR: normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRh: normalization of neutrophil count (≥ 500/μL) and platelet count (≥ 50,000/μL); other criteria same as defined for CRc.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=51 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Rate of CR+CRc+CRh As Assessed by Investigator in Total R/R BPDCN Participants	—	—	—	—	—	—	17.6 percentage of participants Interval 8.4 to 30.87	—	—

SECONDARY outcome

Timeframe: Up to approximately 81 months

Population: mITT Population included all participants who were eligible based on the screening criteria and who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = Total R/R BPDCN participants with CR, CRc, and CRh. Per protocol, this endpoint evaluated only total R/R BPDCN participants with CR, CRc, and CRh, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.

Duration of CR+CRc+CRh was defined as time from first response to time of relapse or death from any cause, whichever came first. CR: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRh: normalization of neutrophil count (≥ 500/μL) and platelet count (≥ 50,000/μL); other criteria same as defined for CRc.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=5 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Duration of CR+CRc+CRh As Assessed by Investigator in Total R/R BPDCN Participants	—	—	—	—	—	—	9.20 months Interval 0.789 to Data could not be calculated due to insufficient number of events.	—	—

SECONDARY outcome

Timeframe: Up to approximately 81 months

ORR: percentage of participants with CR, CRc, CRh, CRi, and PR. CR, CRc, and CRh as defined in Outcome Measure 20 above. CRi: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) or platelet count (≥100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. PR: Decreased by \> 50% in blast percentage to 5%-25%; 50% to \<100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; ≥50% decrease in the sum of the product of the diameters (SPD) of up to 6 largest dominant masses, no increase in size of other nodes; ≥ 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter), no increase in size of liver of spleen.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=51 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
ORR As Assessed by Investigator in Total R/R BPDCN Participants	—	—	—	—	—	—	35.3 percentage of participants Interval 22.43 to 49.93	—	—

SECONDARY outcome

Timeframe: Up to approximately 81 months

Population: mITT Population included all participants who were eligible based on the screening criteria and who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = Total R/R BPDCN participants with overall response. Per protocol, this endpoint evaluated only total R/R BPDCN participants with overall response, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.

Duration of overall response (CR, CRc, CRh, CRi, and PR) was defined as time from first response to time of relapse or death from any cause, whichever came first. CR, CRc, and CRh, CRi, and PR as defined in Outcome Measure 21 above.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=10 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Duration of Overall Response As Assessed by Investigator in Total R/R BPDCN Participants	—	—	—	—	—	—	4.14 months Interval 1.807 to Data could not be calculated due to insufficient number of events.	—	—

SECONDARY outcome

Timeframe: Up to approximately 81 months

Population: mITT Population included all participants who were eligible based on the screening criteria and who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = Total R/R BPDCN participants. Per protocol, this endpoint evaluated only total R/R BPDCN participants, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.

Overall survival was defined as date of first dose until death from any cause.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=51 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Overall Survival in Total R/R BPDCN Participants	—	—	—	—	—	—	5.78 months Interval 3.943 to 8.378	—	—

SECONDARY outcome

Timeframe: Up to approximately 81 months

Population: mITT Population included all participants who were eligible based on the screening criteria and who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = all frontline BPDCN participants with post-treatment consolidative SCT. Per protocol, this endpoint evaluated only all frontline BPDCN participants with post-treatment consolidative SCT, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=13 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
CCR Rate As Assessed by Investigator in All Frontline BPDCN Participants With Post-Treatment Consolidative Stem Cell Transplant (SCT)	—	—	—	—	—	—	92.3 percentage of participants Interval 63.97 to 99.81	—	—

SECONDARY outcome

Timeframe: Up to approximately 81 months

Population: mITT Population included all participants who were eligible based on the screening criteria and who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = all R/R BPDCN participants with post-treatment consolidative SCT. Per protocol, this endpoint evaluated only all R/R BPDCN participants with post-treatment consolidative SCT, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=6 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
CCR Rate As Assessed by Investigator in All R/R BPDCN Participants With Post-Treatment Consolidative SCT	—	—	—	—	—	—	33.3 percentage of participants Interval 4.33 to 77.72	—	—

SECONDARY outcome

Timeframe: Up to approximately 81 months

Population: The safety population included all participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = BPDCN participants. Per protocol, this endpoint evaluated only BPDCN participants, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.

Post-baseline transfusion independence (red blood cell \[RBC\] and platelet transfusion independence) was defined as any 56-day period after Cycle 1 Day 1 in which the participant did not receive either a RBC or platelet transfusion.

Outcome measures

Outcome measures
Measure	Schedule A: IMGN632 0.45 mg/kg Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.18 mg/kg Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.3 mg/kg Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Schedule A: IMGN632 0.015 mg/kg n=84 Participants Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.045 mg/kg Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Schedule A: IMGN632 0.09 mg/kg Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Percentage of Participants With Post-baseline Transfusion Independence in BPDCN Participants	—	—	—	—	—	—	63.1 percentage of participants Interval 51.87 to 73.37	—	—

Adverse Events

Dose Escalation - Schedule A: IMGN632 0.015 mg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Dose Escalation - Schedule A: IMGN632 0.045 mg/kg

Serious events: 8 serious events

Other events: 12 other events

Deaths: 10 deaths

Dose Escalation - Schedule A: IMGN632 0.09 mg/kg

Serious events: 11 serious events

Other events: 13 other events

Deaths: 12 deaths

Dose Escalation - Schedule A: IMGN632 0.18 mg/kg

Serious events: 7 serious events

Other events: 7 other events

Deaths: 7 deaths

Dose Escalation - Schedule A: IMGN632 0.3 mg/kg

Serious events: 5 serious events

Other events: 5 other events

Deaths: 5 deaths

Dose Escalation - Schedule A: IMGN632 0.45 mg/kg

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

Dose Escalation - Schedule B: IMGN632 0.015 mg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Dose Escalation - Schedule B: IMGN632 0.03 mg/kg

Serious events: 6 serious events

Other events: 5 other events

Deaths: 6 deaths

Dose Escalation - Schedule B: IMGN632 0.06 mg/kg

Serious events: 12 serious events

Other events: 12 other events

Deaths: 12 deaths

Dose Expansion - Schedule A: IMGN632 0.045 mg/kg

Serious events: 66 serious events

Other events: 102 other events

Deaths: 76 deaths

Dose Expansion - Schedule A: IMGN632 0.09 mg/kg

Serious events: 10 serious events

Other events: 10 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Dose Escalation - Schedule A: IMGN632 0.015 mg/kg n=3 participants at risk Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.045 mg/kg n=12 participants at risk Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.09 mg/kg n=13 participants at risk Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.18 mg/kg n=7 participants at risk Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.3 mg/kg n=5 participants at risk Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.45 mg/kg n=2 participants at risk Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg n=3 participants at risk Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg n=6 participants at risk Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg n=14 participants at risk Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Expansion - Schedule A: IMGN632 0.045 mg/kg n=104 participants at risk Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Expansion - Schedule A: IMGN632 0.09 mg/kg n=10 participants at risk Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
BLOOD AND LYMPHATIC SYSTEM DISORDERS ANAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
BLOOD AND LYMPHATIC SYSTEM DISORDERS COAGULOPATHY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
BLOOD AND LYMPHATIC SYSTEM DISORDERS FEBRILE NEUTROPENIA	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	30.8% 4/13 • Number of events 5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	28.6% 2/7 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	40.0% 2/5 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	12.5% 13/104 • Number of events 16 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
BLOOD AND LYMPHATIC SYSTEM DISORDERS NEUTROPENIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
BLOOD AND LYMPHATIC SYSTEM DISORDERS PANCYTOPENIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
BLOOD AND LYMPHATIC SYSTEM DISORDERS THROMBOCYTOPENIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
CARDIAC DISORDERS ATRIAL FIBRILLATION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
CARDIAC DISORDERS CARDIAC ARREST	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
CARDIAC DISORDERS CARDIAC FAILURE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
CARDIAC DISORDERS CARDIAC FAILURE CONGESTIVE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
CARDIAC DISORDERS PERICARDIAL EFFUSION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
CARDIAC DISORDERS STRESS CARDIOMYOPATHY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
EAR AND LABYRINTH DISORDERS EXTERNAL EAR PAIN	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
EAR AND LABYRINTH DISORDERS VERTIGO	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS ASCITES	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS COLITIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS CONSTIPATION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS GASTRIC HAEMORRHAGE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS GASTROINTESTINAL HAEMORRHAGE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS LARGE INTESTINE PERFORATION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS LOWER GASTROINTESTINAL HAEMORRHAGE	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS NAUSEA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS PROCTITIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS RECTAL HAEMORRHAGE	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS SMALL INTESTINAL OBSTRUCTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS VOMITING	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS CHEST PAIN	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS DEATH	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS FATIGUE	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS GENERALISED OEDEMA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS LOCALISED OEDEMA	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS NON-CARDIAC CHEST PAIN	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OEDEMA PERIPHERAL	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	3.8% 4/104 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS PAIN	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS PYREXIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS SUDDEN DEATH	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
HEPATOBILIARY DISORDERS HEPATIC CIRRHOSIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
HEPATOBILIARY DISORDERS HEPATIC FAILURE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
HEPATOBILIARY DISORDERS VENOOCCLUSIVE LIVER DISEASE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
IMMUNE SYSTEM DISORDERS GRAFT VERSUS HOST DISEASE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
IMMUNE SYSTEM DISORDERS GRAFT VERSUS HOST DISEASE IN GASTROINTESTINAL TRACT	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
IMMUNE SYSTEM DISORDERS GRAFT VERSUS HOST DISEASE ORAL	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS ARTHRITIS BACTERIAL	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS BACTERAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS CELLULITIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS CLOSTRIDIUM DIFFICILE INFECTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS COVID-19	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	3.8% 4/104 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS DEVICE RELATED INFECTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS EYE INFECTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS HERPES ZOSTER	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS HERPES ZOSTER DISSEMINATED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS INFLUENZA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS KLEBSIELLA BACTERAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS MUCOSAL INFECTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS PHARYNGITIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS PLEURAL INFECTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS PNEUMOCYSTIS JIROVECII PNEUMONIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS PNEUMONIA	66.7% 2/3 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	25.0% 3/12 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	38.5% 5/13 • Number of events 6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	42.9% 3/7 • Number of events 6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	40.0% 2/5 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 3/6 • Number of events 5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	28.6% 4/14 • Number of events 5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.6% 11/104 • Number of events 11 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS PNEUMONIA FUNGAL	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS PNEUMONIA STAPHYLOCOCCAL	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS PULMONARY SEPSIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS SEPSIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 2/12 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	40.0% 2/5 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	6.7% 7/104 • Number of events 8 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS SINUSITIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS SKIN INFECTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS SOFT TISSUE INFECTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS STREPTOCOCCAL BACTERAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS TOOTH INFECTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS UPPER RESPIRATORY TRACT INFECTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS URINARY TRACT INFECTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS WOUND INFECTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS FALL	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS HIP FRACTURE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS INFUSION RELATED REACTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	28.6% 2/7 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	4.8% 5/104 • Number of events 7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS OVERDOSE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS ROAD TRAFFIC ACCIDENT	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS SUBDURAL HAEMATOMA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS TRANSFUSION REACTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS URINARY TRACT PROCEDURAL COMPLICATION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS AMYLASE INCREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS BLOOD BILIRUBIN INCREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS BLOOD LACTIC ACID INCREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS PLATELET COUNT DECREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS WHITE BLOOD CELL COUNT DECREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS DEHYDRATION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS FAILURE TO THRIVE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS HYPERGLYCAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS HYPERURICAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS HYPONATRAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS TUMOUR LYSIS SYNDROME	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS ARTHRALGIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS BONE PAIN	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS MUSCULAR WEAKNESS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS MUSCULOSKELETAL PAIN	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS PAIN IN EXTREMITY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) TUMOUR ASSOCIATED FEVER	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS DEPRESSED LEVEL OF CONSCIOUSNESS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS DYSARTHRIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS FACIAL NERVE DISORDER	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS HAEMORRHAGE INTRACRANIAL	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS HEADACHE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS IIIRD NERVE DISORDER	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS NEUROPATHY PERIPHERAL	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS SEIZURE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS SYNCOPE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
PSYCHIATRIC DISORDERS CONFUSIONAL STATE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
PSYCHIATRIC DISORDERS MENTAL STATUS CHANGES	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RENAL AND URINARY DISORDERS ACUTE KIDNEY INJURY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS HAEMOPTYSIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PLEURAL EFFUSION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PNEUMONITIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	3.8% 4/104 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 2/10 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PULMONARY EMBOLISM	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS RESPIRATORY FAILURE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS PANNICULITIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
VASCULAR DISORDERS DEEP VEIN THROMBOSIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
VASCULAR DISORDERS EMBOLISM	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
VASCULAR DISORDERS HYPOTENSION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
VASCULAR DISORDERS SHOCK	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
VASCULAR DISORDERS SUPERFICIAL VEIN THROMBOSIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
VASCULAR DISORDERS VENOOCCLUSIVE DISEASE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	3.8% 4/104 • Number of events 5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
VASCULAR DISORDERS VENOUS THROMBOSIS LIMB	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	Dose Escalation - Schedule A: IMGN632 0.015 mg/kg n=3 participants at risk Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.045 mg/kg n=12 participants at risk Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.09 mg/kg n=13 participants at risk Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.18 mg/kg n=7 participants at risk Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.3 mg/kg n=5 participants at risk Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule A: IMGN632 0.45 mg/kg n=2 participants at risk Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.015 mg/kg n=3 participants at risk Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.03 mg/kg n=6 participants at risk Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Escalation - Schedule B: IMGN632 0.06 mg/kg n=14 participants at risk Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	Dose Expansion - Schedule A: IMGN632 0.045 mg/kg n=104 participants at risk Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	Dose Expansion - Schedule A: IMGN632 0.09 mg/kg n=10 participants at risk Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
NERVOUS SYSTEM DISORDERS DYSAESTHESIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS DYSGEUSIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS HEADACHE	33.3% 1/3 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	100.0% 2/2 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	17.3% 18/104 • Number of events 25 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS HYPOAESTHESIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	3.8% 4/104 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS LETHARGY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS MEMORY IMPAIRMENT	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS METABOLIC ENCEPHALOPATHY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS NEUROPATHY PERIPHERAL	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS PARAESTHESIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	5.8% 6/104 • Number of events 11 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS PERIPHERAL SENSORY NEUROPATHY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS PRESYNCOPE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS SOMNOLENCE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS SPEECH DISORDER	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS SUBARACHNOID HAEMORRHAGE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS SYNCOPE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS TREMOR	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
PSYCHIATRIC DISORDERS ABNORMAL DREAMS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
PSYCHIATRIC DISORDERS AGITATION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
PSYCHIATRIC DISORDERS ANXIETY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.7% 9/104 • Number of events 9 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
PSYCHIATRIC DISORDERS CONFUSIONAL STATE	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
PSYCHIATRIC DISORDERS DELIRIUM	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
PSYCHIATRIC DISORDERS DEPRESSED MOOD	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
PSYCHIATRIC DISORDERS DEPRESSION	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
PSYCHIATRIC DISORDERS DYSPHORIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
PSYCHIATRIC DISORDERS HALLUCINATION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
PSYCHIATRIC DISORDERS HALLUCINATION, VISUAL	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
PSYCHIATRIC DISORDERS INSOMNIA	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 2/12 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	30.8% 4/13 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	28.6% 2/7 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	18.3% 19/104 • Number of events 19 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
PSYCHIATRIC DISORDERS SLEEP DISORDER	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RENAL AND URINARY DISORDERS ACUTE KIDNEY INJURY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	5.8% 6/104 • Number of events 8 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RENAL AND URINARY DISORDERS CHROMATURIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RENAL AND URINARY DISORDERS DYSURIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RENAL AND URINARY DISORDERS HAEMATURIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RENAL AND URINARY DISORDERS MICTURITION URGENCY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RENAL AND URINARY DISORDERS NOCTURIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 2/12 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RENAL AND URINARY DISORDERS POLLAKIURIA	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RENAL AND URINARY DISORDERS POLYURIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RENAL AND URINARY DISORDERS RENAL FAILURE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RENAL AND URINARY DISORDERS URINARY INCONTINENCE	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RENAL AND URINARY DISORDERS URINARY RETENTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS GENITAL LESION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS MENSTRUAL DISORDER	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS SCROTAL DISORDER	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS SCROTAL OEDEMA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS SCROTAL SWELLING	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS VAGINAL HAEMORRHAGE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS VULVOVAGINAL DISCOMFORT	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS COUGH	33.3% 1/3 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	41.7% 5/12 • Number of events 5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	23.1% 3/13 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	40.0% 2/5 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	21.4% 3/14 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	11.5% 12/104 • Number of events 17 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 5/10 • Number of events 5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS DYSPHONIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS DYSPNOEA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 2/12 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	23.1% 3/13 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.3% 17/104 • Number of events 22 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 2/10 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS DYSPNOEA EXERTIONAL	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	5.8% 6/104 • Number of events 7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS EPISTAXIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 6/12 • Number of events 7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	28.6% 2/7 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	9.6% 10/104 • Number of events 17 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 2/10 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS HAEMOPTYSIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS HYPOXIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	5.8% 6/104 • Number of events 10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 2/10 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS INCREASED BRONCHIAL SECRETION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS OBLITERATIVE BRONCHIOLITIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS OROPHARYNGEAL PAIN	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PAINFUL RESPIRATION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PARANASAL SINUS HYPERSECRETION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PLEURAL EFFUSION	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PLEURITIC PAIN	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 2/10 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PRODUCTIVE COUGH	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PULMONARY EMBOLISM	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PULMONARY HYPERTENSION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PULMONARY OEDEMA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS RESPIRATORY FAILURE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS RESPIRATORY TRACT CONGESTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS RHINITIS ALLERGIC	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS RHINORRHOEA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS SNEEZING	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS TACHYPNOEA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS WHEEZING	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS ALOPECIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS DECUBITUS ULCER	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS ERYTHEMA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 8/104 • Number of events 9 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS ERYTHEMA MULTIFORME	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS HYPERHIDROSIS	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS PAIN OF SKIN	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS PETECHIAE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	6.7% 7/104 • Number of events 8 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS PHOTOSENSITIVITY REACTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS PURPURA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS RASH	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	5.8% 6/104 • Number of events 6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS RASH ERYTHEMATOUS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS RASH MACULAR	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS RASH MACULO-PAPULAR	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS RASH PAPULAR	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS SKIN IRRITATION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS SKIN MASS	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS SKIN ULCER	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS URTICARIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
VASCULAR DISORDERS DEEP VEIN THROMBOSIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 2/12 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
VASCULAR DISORDERS EMBOLISM	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
VASCULAR DISORDERS FLUSHING	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
VASCULAR DISORDERS HAEMATOMA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
VASCULAR DISORDERS HAEMORRHAGE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
VASCULAR DISORDERS HYPERTENSION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 2/12 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	28.6% 2/7 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	5.8% 6/104 • Number of events 7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
VASCULAR DISORDERS HYPOTENSION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 2/12 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	23.1% 3/13 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	3.8% 4/104 • Number of events 6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
VASCULAR DISORDERS ORTHOSTATIC HYPOTENSION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
VASCULAR DISORDERS PALLOR	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
VASCULAR DISORDERS SUPERFICIAL VEIN THROMBOSIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
BLOOD AND LYMPHATIC SYSTEM DISORDERS ANAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	25.0% 3/12 • Number of events 10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	21.2% 22/104 • Number of events 63 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	30.0% 3/10 • Number of events 11 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
BLOOD AND LYMPHATIC SYSTEM DISORDERS FEBRILE NEUTROPENIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	3.8% 4/104 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 2/10 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
BLOOD AND LYMPHATIC SYSTEM DISORDERS LEUKOCYTOSIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 8/104 • Number of events 11 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
BLOOD AND LYMPHATIC SYSTEM DISORDERS LEUKOPENIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	5.8% 6/104 • Number of events 24 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
BLOOD AND LYMPHATIC SYSTEM DISORDERS LYMPHADENOPATHY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
BLOOD AND LYMPHATIC SYSTEM DISORDERS MYELOSUPPRESSION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
BLOOD AND LYMPHATIC SYSTEM DISORDERS NEUTROPENIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	12.5% 13/104 • Number of events 23 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
BLOOD AND LYMPHATIC SYSTEM DISORDERS SPLENOMEGALY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
BLOOD AND LYMPHATIC SYSTEM DISORDERS THROMBOCYTOPENIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	25.0% 3/12 • Number of events 14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	28.6% 2/7 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	15.4% 16/104 • Number of events 48 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
CARDIAC DISORDERS ATRIAL FIBRILLATION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
CARDIAC DISORDERS ATRIAL FLUTTER	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
CARDIAC DISORDERS BRADYCARDIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
CARDIAC DISORDERS CARDIOMEGALY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
CARDIAC DISORDERS EXTRASYSTOLES	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
CARDIAC DISORDERS HEART FAILURE WITH PRESERVED EJECTION FRACTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
CARDIAC DISORDERS LEFT VENTRICULAR DYSFUNCTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
CARDIAC DISORDERS LEFT VENTRICULAR FAILURE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
CARDIAC DISORDERS MYOPERICARDITIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
CARDIAC DISORDERS PERICARDIAL EFFUSION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
CARDIAC DISORDERS PERICARDITIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
CARDIAC DISORDERS SINUS TACHYCARDIA	66.7% 2/3 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	4.8% 5/104 • Number of events 6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
CARDIAC DISORDERS TACHYCARDIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	23.1% 3/13 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	28.6% 2/7 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	5.8% 6/104 • Number of events 10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
EAR AND LABYRINTH DISORDERS EAR PAIN	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
EAR AND LABYRINTH DISORDERS VERTIGO	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
ENDOCRINE DISORDERS ADRENAL INSUFFICIENCY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
EYE DISORDERS DRY EYE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	3.8% 4/104 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
EYE DISORDERS EYE DISCHARGE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
EYE DISORDERS EYE PAIN	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
EYE DISORDERS VISION BLURRED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	3.8% 4/104 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
EYE DISORDERS VISUAL IMPAIRMENT	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	3.8% 4/104 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS ABDOMINAL DISCOMFORT	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS ABDOMINAL DISTENSION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	60.0% 3/5 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	4.8% 5/104 • Number of events 5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS ABDOMINAL PAIN	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	25.0% 3/12 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	30.8% 4/13 • Number of events 5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	28.6% 2/7 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	21.4% 3/14 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 8/104 • Number of events 11 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS ABDOMINAL PAIN UPPER	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS ABDOMINAL TENDERNESS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS ANAL INCONTINENCE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS ASCITES	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS CONSTIPATION	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	25.0% 3/12 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	23.1% 3/13 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	60.0% 3/5 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	100.0% 2/2 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	35.7% 5/14 • Number of events 5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	24.0% 25/104 • Number of events 28 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS DENTAL CARIES	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS DIARRHOEA	66.7% 2/3 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	41.7% 5/12 • Number of events 7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	61.5% 8/13 • Number of events 9 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	42.9% 3/7 • Number of events 7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	40.0% 2/5 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	21.4% 3/14 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	21.2% 22/104 • Number of events 24 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	30.0% 3/10 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS DRY MOUTH	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS DYSPEPSIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	3.8% 4/104 • Number of events 5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS DYSPHAGIA	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS FLATULENCE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS GASTROOESOPHAGEAL REFLUX DISEASE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	3.8% 4/104 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS GINGIVAL BLEEDING	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS GINGIVAL HYPERTROPHY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS HAEMORRHOIDS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS INTESTINAL PERFORATION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS LIP SWELLING	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS MELAENA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS MOUTH ULCERATION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS NAUSEA	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 4/12 • Number of events 5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	53.8% 7/13 • Number of events 8 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	28.6% 2/7 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 7/14 • Number of events 7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	21.2% 22/104 • Number of events 25 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS ODYNOPHAGIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS ORAL DISORDER	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS ORAL MUCOSA HAEMATOMA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS ORAL MUCOSAL ERYTHEMA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS ORAL PAIN	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS PARAESTHESIA ORAL	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS PERIODONTAL DISEASE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS PROCTALGIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS SALIVARY GLAND PAIN	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS STOMATITIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 2/12 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	28.6% 2/7 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	6.7% 7/104 • Number of events 7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GASTROINTESTINAL DISORDERS VOMITING	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	25.0% 3/12 • Number of events 5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	23.1% 3/13 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	6.7% 7/104 • Number of events 10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS ASTHENIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	12.5% 13/104 • Number of events 14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS CHEST DISCOMFORT	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS CHEST PAIN	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS CHILLS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	41.7% 5/12 • Number of events 5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	23.1% 3/13 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	42.9% 3/7 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	40.0% 2/5 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.7% 9/104 • Number of events 11 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS DISCOMFORT	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS FACE OEDEMA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS FATIGUE	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 4/12 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	28.6% 2/7 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	21.4% 3/14 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	27.9% 29/104 • Number of events 38 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 5/10 • Number of events 6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS GAIT DISTURBANCE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	6.7% 7/104 • Number of events 7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS MALAISE	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	25.0% 3/12 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS NON-CARDIAC CHEST PAIN	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OEDEMA PERIPHERAL	66.7% 2/3 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 2/12 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	23.1% 3/13 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	40.0% 2/5 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	100.0% 2/2 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 3/6 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	21.4% 3/14 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	47.1% 49/104 • Number of events 89 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	40.0% 4/10 • Number of events 7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS PAIN	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS PERIPHERAL SWELLING	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS PYREXIA	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 4/12 • Number of events 5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	23.1% 3/13 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	28.6% 2/7 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 2/6 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	28.6% 4/14 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	15.4% 16/104 • Number of events 23 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 2/10 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS TEMPERATURE INTOLERANCE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
HEPATOBILIARY DISORDERS CHOLECYSTITIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
HEPATOBILIARY DISORDERS CHOLELITHIASIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
HEPATOBILIARY DISORDERS GALLBLADDER ENLARGEMENT	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
HEPATOBILIARY DISORDERS HEPATOMEGALY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
HEPATOBILIARY DISORDERS HEPATOSPLENOMEGALY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
HEPATOBILIARY DISORDERS HYPERPLASTIC CHOLECYSTOPATHY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
HEPATOBILIARY DISORDERS JAUNDICE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
IMMUNE SYSTEM DISORDERS HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
IMMUNE SYSTEM DISORDERS HYPOGAMMAGLOBULINAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS CELLULITIS	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 2/12 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 8/104 • Number of events 8 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS CONJUNCTIVITIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS CYTOMEGALOVIRUS INFECTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS DIVERTICULITIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS ENTEROCOCCAL BACTERAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS ENTEROCOCCAL INFECTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS ESCHERICHIA URINARY TRACT INFECTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS FOLLICULITIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS FUNGAL SKIN INFECTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS LARYNGITIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS ORAL CANDIDIASIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS ORAL HERPES	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	25.0% 3/12 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS PARAINFLUENZAE VIRUS INFECTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS PHARYNGITIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS PNEUMONIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS PNEUMONIA KLEBSIELLA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS SKIN INFECTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS URINARY TRACT INFECTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	4.8% 5/104 • Number of events 6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS VAGINAL INFECTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS VIRAL UPPER RESPIRATORY TRACT INFECTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INFECTIONS AND INFESTATIONS VULVAL ABSCESS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS CONTUSION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	5.8% 6/104 • Number of events 6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS FALL	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	25.0% 3/12 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	11.5% 12/104 • Number of events 13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS INCISION SITE PAIN	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS INFUSION RELATED REACTION	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	28.6% 2/7 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	40.0% 2/5 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	21.4% 3/14 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	23.1% 24/104 • Number of events 46 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 5/10 • Number of events 6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS JOINT INJURY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS LIMB INJURY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS OPTIC NERVE INJURY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS POST PROCEDURAL HAEMORRHAGE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS SKIN ABRASION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS SKIN LACERATION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS TONGUE INJURY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS TRANSFUSION REACTION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS WOUND	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS ALANINE AMINOTRANSFERASE INCREASED	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 2/12 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	30.8% 4/13 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	42.9% 3/7 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	11.5% 12/104 • Number of events 15 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS AMMONIA INCREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 2/12 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	30.8% 4/13 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	28.6% 2/7 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	9.6% 10/104 • Number of events 22 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS BLOOD ALKALINE PHOSPHATASE INCREASED	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 2/12 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	4.8% 5/104 • Number of events 16 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS BLOOD BICARBONATE INCREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS BLOOD BILIRUBIN INCREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 8/104 • Number of events 23 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS BLOOD CREATININE INCREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	28.6% 2/7 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 8/104 • Number of events 12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS BLOOD UREA INCREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS BLOOD URIC ACID INCREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS ELECTROCARDIOGRAM QT PROLONGED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS FIBRIN D DIMER INCREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS INTERNATIONAL NORMALISED RATIO INCREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS LIVER FUNCTION TEST INCREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS LYMPHOCYTE COUNT DECREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	5.8% 6/104 • Number of events 19 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS NEUTROPHIL COUNT DECREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.7% 9/104 • Number of events 12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS OCCULT BLOOD POSITIVE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS OXYGEN SATURATION DECREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS PLATELET COUNT DECREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	12.5% 13/104 • Number of events 38 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS TRANSAMINASES INCREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS TROPONIN I INCREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS URINE OUTPUT DECREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS UROBILINOGEN URINE INCREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS WEIGHT DECREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	6.7% 7/104 • Number of events 8 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS WEIGHT INCREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	3.8% 4/104 • Number of events 9 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS WHITE BLOOD CELL COUNT DECREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	11.5% 12/104 • Number of events 23 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
INVESTIGATIONS WHITE BLOOD CELL COUNT INCREASED	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS DECREASED APPETITE	100.0% 3/3 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	40.0% 2/5 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	15.4% 16/104 • Number of events 19 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS DEHYDRATION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS GOUT	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS HYPERGLYCAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	100.0% 3/3 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.4% 15/104 • Number of events 24 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 2/10 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS HYPERKALAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 2/6 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS HYPERMAGNESAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS HYPERNATRAEMIA	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS HYPERPHOSPHATAEMIA	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS HYPERURICAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.7% 9/104 • Number of events 9 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS HYPERVOLAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 2/6 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS HYPOALBUMINAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 2/12 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	13.5% 14/104 • Number of events 30 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS HYPOCALCAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	5.8% 6/104 • Number of events 9 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS HYPOKALAEMIA	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	25.0% 3/12 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	30.8% 4/13 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.2% 21/104 • Number of events 37 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	40.0% 4/10 • Number of events 5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS HYPOMAGNESAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 2/6 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 8/104 • Number of events 10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS HYPONATRAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 8/104 • Number of events 15 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS HYPOPHOSPHATAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 2/12 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	9.6% 10/104 • Number of events 20 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 2/10 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS HYPOPROTEINAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS HYPOVOLAEMIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS MALNUTRITION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS METABOLIC ACIDOSIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS POLYDIPSIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
METABOLISM AND NUTRITION DISORDERS TUMOUR LYSIS SYNDROME	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS ARTHRALGIA	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 2/12 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.7% 9/104 • Number of events 9 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS ARTHRITIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.96% 1/104 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS BACK PAIN	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	38.5% 5/13 • Number of events 5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.7% 9/104 • Number of events 9 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS BONE PAIN	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	3.8% 4/104 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS HAEMATOMA MUSCLE	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS MUSCLE SPASMS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS MUSCULAR WEAKNESS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	6.7% 7/104 • Number of events 7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS MUSCULOSKELETAL CHEST PAIN	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	50.0% 1/2 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	3.8% 4/104 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS MUSCULOSKELETAL PAIN	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS MYALGIA	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	3.8% 4/104 • Number of events 4 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS NECK PAIN	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	40.0% 2/5 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	2.9% 3/104 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS PAIN IN EXTREMITY	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	13.5% 14/104 • Number of events 16 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS PAIN IN JAW	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS ROTATOR CUFF SYNDROME	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS SOFT TISSUE DISORDER	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) SQUAMOUS CELL CARCINOMA OF SKIN	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS APHASIA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	1.9% 2/104 • Number of events 2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS ASTERIXIS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS AURA	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	10.0% 1/10 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS CERVICAL CORD COMPRESSION	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS COGNITIVE LINGUISTIC DEFICIT	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/104 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.
NERVOUS SYSTEM DISORDERS DIZZINESS	0.00% 0/3 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	11.5% 12/104 • Number of events 19 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to approximately 81 months The safety population included all participants who received at least 1 dose of study drug.

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER