Trial Outcomes & Findings for An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies (NCT NCT02712905)

NCT ID: NCT02712905

Last Updated: 2025-11-04

Results Overview

Adverse events (AEs) were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 116 participants
• Primary outcome timeframe: up to 588 days
• Results posted on: 2025-11-04

Participant Flow

Participants were enrolled at 12 study sites: 10 in the United States and 1 each in Belgium and the Netherlands.

Participant milestones

Measure	Group A: INCB059872 Monotherapy; 2 mg QOD Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received oral INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD Participants with AML or MDS received oral INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD Participants with AML or MDS received oral INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD Participants with AML or MDS received oral INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD Participants with AML or MDS received oral INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD Participants with AML or MDS received oral INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 1 mg QD Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received oral INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group C: Combination Therapy; INCB059872 2 mg QD + ATRA Participants with relapsed/refractory AML received oral INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared \[m\^2\] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.	Group C: Combination Therapy; INCB059872 3 mg QD + ATRA Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.	Group C: Combination Therapy; INCB059872 4 mg QD + ATRA Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.	Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.	Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.	Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.
Combination Therapy STARTED	0	0	0	0	0	0	0	0	0	0	0	0	5	7	1	7	1	6
Combination Therapy COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Combination Therapy NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	5	7	1	7	1	6
Monotherapy STARTED	3	6	1	5	18	2	3	3	1	36	3	7	0	0	0	0	0	0
Monotherapy COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Monotherapy NOT COMPLETED	3	6	1	5	18	2	3	3	1	36	3	7	0	0	0	0	0	0

Reasons for withdrawal

Measure	Group A: INCB059872 Monotherapy; 2 mg QOD Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received oral INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD Participants with AML or MDS received oral INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD Participants with AML or MDS received oral INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD Participants with AML or MDS received oral INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD Participants with AML or MDS received oral INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD Participants with AML or MDS received oral INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 1 mg QD Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received oral INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group C: Combination Therapy; INCB059872 2 mg QD + ATRA Participants with relapsed/refractory AML received oral INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared \[m\^2\] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.	Group C: Combination Therapy; INCB059872 3 mg QD + ATRA Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.	Group C: Combination Therapy; INCB059872 4 mg QD + ATRA Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.	Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.	Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.	Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.
Monotherapy Death	2	5	0	3	15	1	3	3	0	27	2	5	0	0	0	0	0	0
Monotherapy Lost to Follow-up	0	1	0	1	0	0	0	0	0	2	0	0	0	0	0	0	0	0
Monotherapy Adverse Event	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Combination Therapy Death	0	0	0	0	0	0	0	0	0	0	0	0	5	6	1	3	1	3
Combination Therapy Study Terminated by Sponsor	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	2	0	1
Combination Therapy Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	2
Combination Therapy Unknown; Did Not Complete End of Study Case Report Form Prior to Site Closure	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Monotherapy Physician Decision	1	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Monotherapy Study Terminated by Sponsor	0	0	0	0	1	0	0	0	0	2	0	0	0	0	0	0	0	0
Monotherapy Withdrawal by Subject	0	0	1	0	2	0	0	0	0	4	1	2	0	0	0	0	0	0
Monotherapy Started New Cancer Drug	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0

Baseline Characteristics

For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).

Baseline characteristics by cohort

Measure	Group B: INCB059872 Monotherapy; 3 mg QD n=3 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD n=7 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QOD n=3 Participants Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received oral INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD n=6 Participants Participants with AML or MDS received oral INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD n=1 Participants Participants with AML or MDS received oral INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD n=5 Participants Participants with AML or MDS received oral INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD n=18 Participants Participants with AML or MDS received oral INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD n=2 Participants Participants with AML or MDS received oral INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 1 mg QD n=3 Participants Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received oral INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD n=3 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD n=1 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD n=36 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group C: Combination Therapy; INCB059872 2 mg QD + ATRA n=5 Participants Participants with relapsed/refractory AML received oral INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared \[m\^2\] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.	Group C: Combination Therapy; INCB059872 3 mg QD + ATRA n=7 Participants Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.	Group C: Combination Therapy; INCB059872 4 mg QD + ATRA n=1 Participants Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.	Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine n=7 Participants Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.	Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine n=1 Participants Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.	Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab n=6 Participants Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.	Total n=115 Participants Total of all reporting groups
Sex: Female, Male Female	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	4 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	3 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	3 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	3 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	9 Participants n=18 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	2 Participants n=2 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	1 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	3 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	16 Participants n=36 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	4 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	3 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	3 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	54 Participants n=111 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	1 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	2 Participants n=18 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	1 Participants n=2 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=36 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	4 Participants n=111 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	7 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	3 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	5 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	5 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	16 Participants n=18 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	1 Participants n=2 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	3 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	3 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	36 Participants n=36 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	5 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	7 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	7 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	6 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	107 Participants n=111 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=18 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=2 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=36 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=111 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).
Race/Ethnicity, Customized White	3 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	6 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	3 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	4 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	4 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	15 Participants n=18 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	2 Participants n=2 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	2 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	2 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	31 Participants n=36 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	5 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	6 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	7 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	6 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	96 Participants n=111 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).
Race/Ethnicity, Customized Black or African American	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	1 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	2 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	1 Participants n=18 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=2 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	1 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	3 Participants n=36 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	8 Participants n=111 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).
Race/Ethnicity, Customized Asian	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=18 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=2 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	1 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	1 Participants n=36 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	2 Participants n=111 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).
Race/Ethnicity, Customized Non-White	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	1 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=18 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=2 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=36 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	1 Participants n=111 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).
Race/Ethnicity, Customized Unknown/Not Specified	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	1 Participants n=18 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=2 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	1 Participants n=36 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	2 Participants n=111 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).
Race/Ethnicity, Customized Declined to Report	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=18 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=2 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=36 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	1 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	1 Participants n=111 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).
Age, Continuous	51.0 years STANDARD_DEVIATION 11.53 • n=3 Participants	63.0 years STANDARD_DEVIATION 4.86 • n=7 Participants	65.0 years STANDARD_DEVIATION 5.20 • n=3 Participants	58.0 years STANDARD_DEVIATION 9.53 • n=6 Participants	NA years STANDARD_DEVIATION NA • n=1 Participants	57.4 years STANDARD_DEVIATION 21.93 • n=5 Participants	63.8 years STANDARD_DEVIATION 12.02 • n=18 Participants	51.0 years STANDARD_DEVIATION 18.38 • n=2 Participants	46.3 years STANDARD_DEVIATION 22.59 • n=3 Participants	63.0 years STANDARD_DEVIATION 17.09 • n=3 Participants	NA years STANDARD_DEVIATION NA • n=1 Participants	57.8 years STANDARD_DEVIATION 13.95 • n=36 Participants	61.0 years STANDARD_DEVIATION 9.19 • n=5 Participants	63.6 years STANDARD_DEVIATION 13.83 • n=7 Participants	NA years STANDARD_DEVIATION NA • n=1 Participants	73.4 years STANDARD_DEVIATION 9.02 • n=7 Participants	NA years STANDARD_DEVIATION NA • n=1 Participants	68.7 years STANDARD_DEVIATION 9.48 • n=6 Participants	60.8 years STANDARD_DEVIATION 13.39 • n=115 Participants
Sex: Female, Male Male	3 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	3 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	3 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	2 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	9 Participants n=18 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=2 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	2 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	20 Participants n=36 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	5 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	3 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	4 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	3 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	57 Participants n=111 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).
Race/Ethnicity, Customized American-Indian/Alaska Native	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	1 Participants n=18 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=2 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=3 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=36 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=5 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=7 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	—	0 Participants n=6 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).	1 Participants n=111 Participants • For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).

PRIMARY outcome

Timeframe: up to 588 days

Population: Safety Population: all enrolled participants who received at least 1 dose of INCB059872, ATRA, azacitidine, or nivolumab

Adverse events (AEs) were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug.

Outcome measures

Measure	Group B: INCB059872 Monotherapy; 1 mg QD n=3 Participants Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD n=3 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD n=1 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD n=36 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD n=3 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD n=7 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QOD n=3 Participants Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD n=6 Participants Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD n=1 Participants Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD n=5 Participants Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD n=18 Participants Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD n=2 Participants Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
Number of Participants Receiving INCB059872 Monotherapy With Any Treatment-emergent Adverse Event (TEAE)	3 Participants	3 Participants	1 Participants	36 Participants	3 Participants	7 Participants	3 Participants	6 Participants	1 Participants	5 Participants	18 Participants	2 Participants

PRIMARY outcome

Timeframe: up to 1387 days

Population: Safety Population

AEs were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug.

Outcome measures

Measure	Group B: INCB059872 Monotherapy; 1 mg QD Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QOD n=5 Participants Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD n=7 Participants Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD n=1 Participants Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD n=7 Participants Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD n=1 Participants Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD n=6 Participants Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
Number of Participants Receiving INCB059872 Combination Therapy With Any TEAE	—	—	—	—	—	—	5 Participants	7 Participants	1 Participants	7 Participants	1 Participants	6 Participants

SECONDARY outcome

Timeframe: up to 518 days

Population: Full Analysis Set: all enrolled participants who received at least 1 dose of INCB059872, ATRA, azacitidine, or nivolumab. Only participants with the indicated type of solid tumor who received monotherapy were analyzed.

ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or a partial response (PR), per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1), recorded before and including the first event of progressive disease (PD). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

Outcome measures

Measure	Group B: INCB059872 Monotherapy; 1 mg QD n=3 Participants Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD n=3 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD n=1 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD n=36 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD n=3 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD n=7 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QOD Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
Objective Response Rate (ORR) in Participants With the Indicated Type of Solid Tumors Who Received INCB059872 Monotherapy SCLC	—	—	—	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—	—	—	—	—	—
Objective Response Rate (ORR) in Participants With the Indicated Type of Solid Tumors Who Received INCB059872 Monotherapy Ewing's sarcoma	—	—	—	0.0 percentage of participants	—	—	—	—	—	—	—	—
Objective Response Rate (ORR) in Participants With the Indicated Type of Solid Tumors Who Received INCB059872 Monotherapy Poorly differentiated neuroendocrine tumors	0.0 percentage of participants	—	—	0.0 percentage of participants	—	—	—	—	—	—	—	—
Objective Response Rate (ORR) in Participants With the Indicated Type of Solid Tumors Who Received INCB059872 Monotherapy Other solid tumors	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	50.0 percentage of participants	0.0 percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 85 days

Population: Full Analysis Set. Only participants with AML who received monotherapy were analyzed. The participant in Group A receiving 3 mg QOD was on treatment for less than a week and therefore was not evaluated for efficacy.

ORR was defined as the percentage of participants who achieved a best overall response of complete remission or complete remission with incomplete hematologic recovery (CRi), per the International Working Group Response Criteria for AML, recorded before and including the first event of progression (treatment failure, relapse, and PD) based on altering the natural history of the disease. Complete remission: absolute neutrophil count (ANC) ≥1.0 x 10^9/Liter (L), platelet count ≥100 x 10^9/L, bone marrow with less than 5% blast cells, Auer rods not detectable; no platelet, or whole blood transfusions for 7 days prior to the date of the hematology assessment. CRi: complete remission, but the ANC count may be < 1.0 x 10^9/L and/or the platelet count may be <100 x 10^9/L.

Outcome measures

Measure	Group B: INCB059872 Monotherapy; 1 mg QD Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QOD n=3 Participants Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD n=5 Participants Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD n=4 Participants Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD n=12 Participants Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD n=2 Participants Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
ORR for Altering the Natural History of the Disease in Participants With Acute Myeloid Leukemia (AML) Who Received INCB059872 Monotherapy	—	—	—	—	—	—	0.0 percentage of participants	0.0 percentage of participants	—	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: up to 61 days

Population: Full Analysis Set. Only participants with MDS who received monotherapy were analyzed. The participant in Group A receiving 3 mg QOD was on treatment for less than a week and therefore was not evaluated for efficacy.

ORR was defined as the percentage of participants who achieved a best overall response of complete remission, partial remission, or bone marrow complete remission, per the International Working Group Response Criteria for MDS, recorded before and including the first event of progression (treatment failure, relapse after CR or PR, disease transformation, and PD) based on altering the natural history of the disease. Complete remission: <5% bone marrow blasts without evidence of dysplasia; peripheral blood counts: hemoglobin ≥11 grams per deciliter (g/dL), neutrophils ≥1 x 10^9/L, platelets ≥100 x 10^9/L. Partial remission: meeting complete remission criteria, but bone marrow blasts decreased by ≥50% from pre-treatment, but still ≥5%. Bone marrow complete remission: ≤5% bone marrow blasts and decrease by ≥50% from pre-treatment.

Outcome measures

Measure	Group B: INCB059872 Monotherapy; 1 mg QD Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QOD Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD n=1 Participants Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD n=1 Participants Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD n=6 Participants Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
ORR for Altering the Natural History of the Disease in Participants With Myelodysplastic Syndrome (MDS) Who Received INCB059872 Monotherapy	—	—	—	—	—	—	—	0.0 percentage of participants	—	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline; Week 12

Population: Full Analysis Set. Analysis was not conducted because no participants with MF remained in the study at Week 12.

Change from Baseline was to have been calculated as the post-Baseline value minus the Baseline value. SVR was to have been measured by magnetic resonance imaging (MRI), or by computed tomography (CT) scan in participants who were not candidates for MRI or when MRI was not readily available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose

Population: Pharmacokinetic (PK)-Evaluable Population: all participants who received at least 1 dose of study treatment and provided at least 1 postdose PK sample

Cmax was defined as the maximum observed plasma concentration of INCB059872.

Outcome measures

Measure	Group B: INCB059872 Monotherapy; 1 mg QD n=3 Participants Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD n=3 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD n=6 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD n=1 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD n=3 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QOD n=2 Participants Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD n=4 Participants Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD n=3 Participants Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD n=3 Participants Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD n=1 Participants Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
Cmax of INCB059872 in Plasma When Received as Monotherapy	25.7 nanomolar (nM) Standard Deviation 21.8	46.0 nanomolar (nM) Standard Deviation 9.95	—	70.6 nanomolar (nM) Standard Deviation 25.6	NA nanomolar (nM) Standard Deviation NA To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.	98.2 nanomolar (nM) Standard Deviation 28.5	33.4 nanomolar (nM) Standard Deviation 29.2	46.0 nanomolar (nM) Standard Deviation 12.5	—	73.1 nanomolar (nM) Standard Deviation 30.5	110 nanomolar (nM) Standard Deviation 13.7	NA nanomolar (nM) Standard Deviation NA To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.

SECONDARY outcome

Timeframe: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose

Population: Pharmacokinetic (PK)-Evaluable Population

tmax was defined as the time to the maximum observed plasma concentration of INCB059872.

Outcome measures

Measure	Group B: INCB059872 Monotherapy; 1 mg QD n=3 Participants Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD n=3 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD n=6 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD n=1 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD n=3 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QOD n=2 Participants Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD n=4 Participants Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD n=3 Participants Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD n=3 Participants Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD n=1 Participants Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
Tmax of INCB059872 in Plasma When Received as Monotherapy	2.0 hours Interval 0.5 to 2.0	2 hours Interval 0.5 to 2.0	—	1 hours Interval 0.5 to 2.0	NA hours To protect participant privacy and mitigate the risk of re-identification, median (full range) cannot be reported for a single participant.	0.5 hours Interval 0.5 to 1.0	0.5 hours Interval 0.5 to 0.5	1 hours Interval 0.5 to 1.0	—	1 hours Interval 0.5 to 1.0	0.5 hours Interval 0.5 to 1.0	NA hours To protect participant privacy and mitigate the risk of re-identification, median (full range) cannot be reported for a single participant.

SECONDARY outcome

Timeframe: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose

Population: Pharmacokinetic (PK)-Evaluable Population. Only participants with available data were analyzed.

AUC(0-τ) was defined as the area under the plasma concentration-time curve from time = 0 to the end of the dosing period of INCB059872.

Outcome measures

Measure	Group B: INCB059872 Monotherapy; 1 mg QD n=1 Participants Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD n=1 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD n=6 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD n=1 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD n=3 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QOD n=2 Participants Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD n=4 Participants Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD n=3 Participants Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD n=3 Participants Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD n=1 Participants Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
AUC(0-τ) of INCB059872 in Plasma When Received as Monotherapy	NA nM x hour Standard Deviation NA To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.	NA nM x hour Standard Deviation NA To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.	—	361 nM x hour Standard Deviation 115	NA nM x hour Standard Deviation NA To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.	495 nM x hour Standard Deviation 63.2	196 nM x hour Standard Deviation 8.38	216 nM x hour Standard Deviation 75.5	—	374 nM x hour Standard Deviation 120	486 nM x hour Standard Deviation 107	NA nM x hour Standard Deviation NA To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.

SECONDARY outcome

Timeframe: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose

Population: Pharmacokinetic (PK)-Evaluable Population. Only participants with available data were analyzed.

t1/2 was defined as the half-life of INCB059872.

Outcome measures

Measure	Group B: INCB059872 Monotherapy; 1 mg QD n=1 Participants Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD n=1 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD n=6 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD n=1 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD n=3 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QOD n=2 Participants Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD n=4 Participants Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD n=3 Participants Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD n=3 Participants Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD n=1 Participants Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
t1/2 of INCB059872 in Plasma When Received as Monotherapy	NA hours Standard Deviation NA To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.	NA hours Standard Deviation NA To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.	—	3.57 hours Standard Deviation 0.52	NA hours Standard Deviation NA To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.	4.28 hours Standard Deviation 0.25	3.15 hours Standard Deviation 0.189	3.30 hours Standard Deviation 0.765	—	3.13 hours Standard Deviation 0.495	3.67 hours Standard Deviation 1.38	NA hours Standard Deviation NA To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.

SECONDARY outcome

Timeframe: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose

Population: Pharmacokinetic (PK)-Evaluable Population. Only participants with available data were analyzed.

CL/F was defined as the apparent oral clearance of INCB059872.

Outcome measures

Measure	Group B: INCB059872 Monotherapy; 1 mg QD n=1 Participants Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD n=1 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD n=6 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD n=1 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD n=3 Participants Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QOD n=2 Participants Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD n=4 Participants Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD n=3 Participants Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD n=3 Participants Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD n=1 Participants Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
CL/F of INCB059872 in Plasma When Received as Monotherapy	NA Liters per hour Standard Deviation NA To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.	NA Liters per hour Standard Deviation NA To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.	—	23.1 Liters per hour Standard Deviation 6.32	NA Liters per hour Standard Deviation NA To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.	21.1 Liters per hour Standard Deviation 2.74	32.9 Liters per hour Standard Deviation 7.94	26.3 Liters per hour Standard Deviation 9.31	—	22.1 Liters per hour Standard Deviation 6.56	22.1 Liters per hour Standard Deviation 5.57	NA Liters per hour Standard Deviation NA To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.

SECONDARY outcome

Timeframe: up to 1353 days

Population: Full Analysis Set. Only participants with SCLC who received combination therapy and had available data were analyzed.

ORR was defined as the percentage of participants who achieved a best overall response of CR or a PR, per investigator assessment according to RESIST v1.1, recorded before and including the first event of PD. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

Outcome measures

Measure	Group B: INCB059872 Monotherapy; 1 mg QD Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QOD Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD n=5 Participants Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
ORR in Participants With SCLC Who Received Combination Therapy	—	—	—	—	—	—	—	—	—	—	—	20.0 percentage of participants

SECONDARY outcome

Timeframe: up to 208 days

Population: Full Analysis Set. Only participants with AML who received combination therapy were analyzed.

ORR was defined as the percentage of participants who achieved a best overall response of complete remission or CRi, per the International Working Group Response Criteria for AML, recorded before and including the first event of progression (treatment failure, relapse, and PD) based on altering the natural history of the disease. Complete remission: ANC ≥1.0 x 10^9/L, platelet count ≥100 x 10^9/L, bone marrow with less than 5% blast cells, Auer rods not detectable; no platelet, or whole blood transfusions for 7 days prior to the date of the hematology assessment. CRi: complete remission, but the ANC count may be < 1.0 x 10^9/L and/or the platelet count may be <100 x 10^9/L.

Outcome measures

Measure	Group B: INCB059872 Monotherapy; 1 mg QD Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QOD n=5 Participants Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD n=7 Participants Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD n=1 Participants Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD n=6 Participants Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD n=1 Participants Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
ORR for Altering the Natural History of the Disease in Participants With AML Who Received Combination Therapy	—	—	—	—	—	—	20.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	16.7 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: up to 85 days

Population: Full Analysis Set. Only participants with MDS who received combination therapy were analyzed.

ORR was defined as the percentage of participants who achieved a best overall response of complete remission, partial remission, or bone marrow complete remission, per the International Working Group Response Criteria for MDS, recorded before and including the first event of progression (treatment failure, relapse after CR or PR, disease transformation, and PD) based on altering the natural history of the disease. Complete remission: <5% bone marrow blasts without evidence of dysplasia; peripheral blood counts: hemoglobin ≥11 g/dL, neutrophils ≥1 x 10^9/L, platelets ≥100 x 10^9/L. Partial remission: meeting complete remission criteria, but bone marrow blasts decreased by ≥50% from pre-treatment, but still ≥5%. Bone marrow complete remission: ≤5% bone marrow blasts and decrease by ≥50% from pre-treatment.

Outcome measures

Measure	Group B: INCB059872 Monotherapy; 1 mg QD Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QOD Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD n=1 Participants Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
ORR for Altering the Natural History of the Disease in Participants With MDS Who Received Combination Therapy	—	—	—	—	—	—	—	—	—	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose

Population: PK-Evaluable Population

Cmax was defined as the maximum observed plasma concentration of INCB059872.

Outcome measures

Measure	Group B: INCB059872 Monotherapy; 1 mg QD Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QOD n=4 Participants Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD n=2 Participants Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD n=3 Participants Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD n=5 Participants Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
Cmax of INCB059872 in Plasma When Received as Combination Therapy	—	—	—	—	—	—	44.3 nM Standard Deviation 16.4	96.4 nM Standard Deviation 10.7	—	38.2 nM Standard Deviation 33.5	—	78.0 nM Standard Deviation 26.3

SECONDARY outcome

Timeframe: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose

Population: PK-Evaluable Population

tmax was defined as the time to the maximum observed plasma concentration of INCB059872.

Outcome measures

Measure	Group B: INCB059872 Monotherapy; 1 mg QD Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QOD n=4 Participants Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD n=2 Participants Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD n=3 Participants Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD n=5 Participants Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
Tmax of INCB059872 in Plasma When Received as Combination Therapy	—	—	—	—	—	—	1.0 hours Interval 0.5 to 1.0	0.5 hours Interval 0.5 to 0.5	—	0.5 hours Interval 0.0 to 1.0	—	1.0 hours Interval 0.5 to 1.0

SECONDARY outcome

Timeframe: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose

Population: PK-Evaluable Population

AUC(0-τ) was defined as the area under the plasma concentration-time curve from time = 0 to the end of the dosing period of INCB059872.

Outcome measures

Measure	Group B: INCB059872 Monotherapy; 1 mg QD Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QOD n=4 Participants Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD n=2 Participants Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD n=3 Participants Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD n=5 Participants Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
AUC(0-τ) of INCB059872 in Plasma When Received as Combination Therapy	—	—	—	—	—	—	225 nM x hour Standard Deviation 85.9	377 nM x hour Standard Deviation 25.7	—	273 nM x hour Standard Deviation 24.4	—	357 nM x hour Standard Deviation 97.5

SECONDARY outcome

Timeframe: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose

Population: PK-Evaluable Population

t1/2 was defined as the half-life of INCB059872.

Outcome measures

Measure	Group B: INCB059872 Monotherapy; 1 mg QD Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QOD n=4 Participants Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD n=2 Participants Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD n=3 Participants Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD n=5 Participants Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
t1/2 of INCB059872 in Plasma When Received as Combination Therapy	—	—	—	—	—	—	3.95 hours Standard Deviation 0.499	3.41 hours Standard Deviation 0.281	—	3.08 hours Standard Deviation 0.040	—	3.79 hours Standard Deviation 0.852

SECONDARY outcome

Timeframe: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose

Population: PK-Evaluable Population

CL/F was defined as the apparent oral clearance of INCB059872.

Outcome measures

Measure	Group B: INCB059872 Monotherapy; 1 mg QD Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QOD n=4 Participants Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD n=2 Participants Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD n=3 Participants Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD n=5 Participants Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
CL/F of INCB059872 in Plasma When Received as Combination Therapy	—	—	—	—	—	—	25.1 Liters per hour Standard Deviation 7.21	20.7 Liters per hour Standard Deviation 1.41	—	19.0 Liters per hour Standard Deviation 1.70	—	23.5 Liters per hour Standard Deviation 8.14

Adverse Events

Group A: INCB059872 Monotherapy; 2 mg QOD

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Group A: INCB059872 Monotherapy; 2 mg QD

Serious events: 5 serious events

Other events: 6 other events

Deaths: 5 deaths

Group A: INCB059872 Monotherapy; 3 mg QOD

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Group A: INCB059872 Monotherapy; 3 mg QD

Serious events: 3 serious events

Other events: 5 other events

Deaths: 4 deaths

Group A: INCB059872 Monotherapy; 4 mg QD

Serious events: 10 serious events

Other events: 17 other events

Deaths: 15 deaths

Group A: INCB059872 Monotherapy; 5 mg QD

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

Group B: INCB059872 Monotherapy; 1 mg QD

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Group B: INCB059872 Monotherapy; 2 mg QOD

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Group B: INCB059872 Monotherapy; 2 mg QD

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Group B: INCB059872 Monotherapy; 3 mg QOD

Serious events: 24 serious events

Other events: 35 other events

Deaths: 27 deaths

Group B: INCB059872 Monotherapy; 3 mg QD

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Group B: INCB059872 Monotherapy; 4 mg QOD

Serious events: 3 serious events

Other events: 7 other events

Deaths: 5 deaths

Group C: Combination Therapy; INCB059872 2 mg QD + ATRA

Serious events: 4 serious events

Other events: 4 other events

Deaths: 5 deaths

Group C: Combination Therapy; INCB059872 3 mg QD + ATRA

Serious events: 4 serious events

Other events: 7 other events

Deaths: 6 deaths

Group C: Combination Therapy; INCB059872 4 mg QD + ATRA

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine

Serious events: 6 serious events

Other events: 7 other events

Deaths: 3 deaths

Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab

Serious events: 2 serious events

Other events: 6 other events

Deaths: 3 deaths

Serious adverse events

Measure	Group A: INCB059872 Monotherapy; 2 mg QOD n=3 participants at risk Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD n=6 participants at risk Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD n=1 participants at risk Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD n=5 participants at risk Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD n=18 participants at risk Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD n=2 participants at risk Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 1 mg QD n=3 participants at risk Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD n=3 participants at risk Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD n=1 participants at risk Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD n=36 participants at risk Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD n=3 participants at risk Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD n=7 participants at risk Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group C: Combination Therapy; INCB059872 2 mg QD + ATRA n=5 participants at risk Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared \[m\^2\] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.	Group C: Combination Therapy; INCB059872 3 mg QD + ATRA n=7 participants at risk Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.	Group C: Combination Therapy; INCB059872 4 mg QD + ATRA n=1 participants at risk Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.	Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine n=7 participants at risk Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.	Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine n=1 participants at risk Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.	Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab n=6 participants at risk Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	8.3% 3/36 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Acute febrile neutrophilic dermatosis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Endocrine disorders Adrenal haemorrhage	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
General disorders Pyrexia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Atypical pneumonia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Bacteraemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Hepatobiliary disorders Biliary obstruction	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Blast cell crisis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Bronchitis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Cardiac disorders Cardiac failure	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Cardiac disorders Cardiac failure congestive	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Cellulitis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Hepatobiliary disorders Cholangitis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Psychiatric disorders Confusional state	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Constipation	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	8.3% 3/36 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Enterococcal bacteraemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Escherichia bacteraemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 6/18 • Number of events 8 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 2/2 • Number of events 4 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	60.0% 3/5 • Number of events 5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	28.6% 2/7 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Gastrointestinal haemorrhage	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
General disorders General physical health deterioration	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Nervous system disorders Haemorrhage intracranial	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Nervous system disorders Headache	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Hepatobiliary disorders Hepatic failure	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Vascular disorders Hypotension	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Klebsiella bacteraemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 1/1 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Nervous system disorders Myasthenic syndrome	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Nausea	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	11.1% 2/18 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
General disorders Non-cardiac chest pain	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Pancreatitis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Perirectal abscess	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Pneumonia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	11.1% 2/18 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Pneumonia fungal	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Sepsis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 2/6 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Septic shock	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Vascular disorders Shock haemorrhagic	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Staphylococcal skin infection	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Swollen tongue	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 1/1 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Tongue haemorrhage	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Tooth infection	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Cardiac disorders Tricuspid valve incompetence	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Renal and urinary disorders Urinary retention	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Urinary tract infection bacterial	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Vomiting	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.

Other adverse events

Measure	Group A: INCB059872 Monotherapy; 2 mg QOD n=3 participants at risk Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 2 mg QD n=6 participants at risk Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QOD n=1 participants at risk Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 3 mg QD n=5 participants at risk Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 4 mg QD n=18 participants at risk Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group A: INCB059872 Monotherapy; 5 mg QD n=2 participants at risk Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 1 mg QD n=3 participants at risk Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QOD n=3 participants at risk Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 2 mg QD n=1 participants at risk Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QOD n=36 participants at risk Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 3 mg QD n=3 participants at risk Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.	Group B: INCB059872 Monotherapy; 4 mg QOD n=7 participants at risk Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.	Group C: Combination Therapy; INCB059872 2 mg QD + ATRA n=5 participants at risk Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared \[m\^2\] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.	Group C: Combination Therapy; INCB059872 3 mg QD + ATRA n=7 participants at risk Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.	Group C: Combination Therapy; INCB059872 4 mg QD + ATRA n=1 participants at risk Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.	Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine n=7 participants at risk Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.	Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine n=1 participants at risk Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.	Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab n=6 participants at risk Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 6/36 • Number of events 6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Actinomycosis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Endocrine disorders Adrenal insufficiency	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Investigations Alanine aminotransferase increased	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	40.0% 2/5 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	44.4% 8/18 • Number of events 8 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	8.3% 3/36 • Number of events 4 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 2/6 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Psychiatric disorders Anxiety	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 1/1 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	22.2% 4/18 • Number of events 4 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	13.9% 5/36 • Number of events 5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 3/6 • Number of events 4 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	8.3% 3/36 • Number of events 4 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
General disorders Asthenia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	11.1% 2/18 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Cardiac disorders Atrial enlargement	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
General disorders Axillary pain	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	8.3% 3/36 • Number of events 4 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Blister	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
General disorders Chest pain	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	8.3% 3/36 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Investigations Blood bilirubin increased	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	8.3% 3/36 • Number of events 4 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	28.6% 2/7 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Blood blister	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Investigations Blood creatinine increased	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 1/1 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 1/1 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Investigations Blood thyroid stimulating hormone	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Investigations Blood triglycerides increased	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Investigations Blood urea increased	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Reproductive system and breast disorders Breast pain	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Reproductive system and breast disorders Breast tenderness	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Bronchitis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Nervous system disorders Burning sensation	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Catheter site cellulitis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Cellulitis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	11.1% 2/18 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Nervous system disorders Cerebral infarction	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Cheilitis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
General disorders Chest discomfort	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
General disorders Chills	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	11.1% 2/18 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Musculoskeletal and connective tissue disorders Chondrocalcinosis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Eye disorders Conjunctival haemorrhage	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Constipation	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 2/6 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	11.1% 2/18 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	19.4% 7/36 • Number of events 8 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	28.6% 2/7 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	71.4% 5/7 • Number of events 5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Injury, poisoning and procedural complications Contusion	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	42.9% 3/7 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 2/6 • Number of events 4 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Ear and labyrinth disorders Deafness neurosensory	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 2/6 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	27.8% 5/18 • Number of events 5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	19.4% 7/36 • Number of events 7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	28.6% 2/7 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 3/6 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Psychiatric disorders Delirium	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Psychiatric disorders Depression	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	8.3% 3/36 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	40.0% 2/5 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 3/18 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 3/3 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	11.1% 4/36 • Number of events 5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 2/6 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Nervous system disorders Dizziness	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 1/1 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	11.1% 2/18 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 1/1 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 1/1 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Nervous system disorders Dysgeusia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	40.0% 2/5 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 3/18 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	11.1% 4/36 • Number of events 4 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	66.7% 2/3 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	42.9% 3/7 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	40.0% 2/5 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	28.6% 2/7 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 3/18 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	19.4% 7/36 • Number of events 7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Renal and urinary disorders Dysuria	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Ear and labyrinth disorders Ear pain	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Ecchymosis	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	28.6% 2/7 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 1/1 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	28.6% 2/7 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Eye disorders Eye inflammation	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Eye disorders Eye irritation	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
General disorders Face oedema	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	66.7% 2/3 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
General disorders Fatigue	100.0% 3/3 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	40.0% 2/5 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 6/18 • Number of events 6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	66.7% 2/3 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	66.7% 2/3 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	47.2% 17/36 • Number of events 19 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	66.7% 2/3 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	57.1% 4/7 • Number of events 4 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	28.6% 2/7 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	42.9% 3/7 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	83.3% 5/6 • Number of events 6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Blood and lymphatic system disorders Febrile neutropenia	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 3/18 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Vascular disorders Haematoma	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Flatulence	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Fungal infection	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
General disorders Gait disturbance	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Gingival bleeding	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Gingival hypertrophy	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Gingival pain	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Gingivitis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Haematochezia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Renal and urinary disorders Haematuria	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Blood and lymphatic system disorders Haemorrhagic diathesis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Nervous system disorders Headache	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 1/1 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	40.0% 2/5 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	11.1% 2/18 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	28.6% 2/7 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 1/1 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 1/1 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
General disorders Hernia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Herpes simplex	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Herpes zoster	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 1/1 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Vascular disorders Hypertension	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	8.3% 3/36 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Vascular disorders Hypotension	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Ear and labyrinth disorders Hypoacusis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	8.3% 3/36 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 3/18 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	8.3% 3/36 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Metabolism and nutrition disorders Hypomagnesaemia	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	11.1% 4/36 • Number of events 4 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	40.0% 2/5 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	8.3% 3/36 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Endocrine disorders Hypothyroidism	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Blood and lymphatic system disorders Increased tendency to bruise	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
General disorders Influenza like illness	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
General disorders Injection site erythema	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
General disorders Injection site reaction	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	28.6% 2/7 • Number of events 4 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Psychiatric disorders Insomnia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	13.9% 5/36 • Number of events 5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Investigations International normalised ratio increased	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Eye disorders Lacrimation increased	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Laryngeal haemorrhage	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	11.1% 2/18 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	66.7% 2/3 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Lip dry	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Investigations Lymphocyte count decreased	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 3/18 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 1/1 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Melaena	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Musculoskeletal and connective tissue disorders Muscular weakness	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	8.3% 3/36 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 2/6 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Nail infection	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	38.9% 7/18 • Number of events 7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	66.7% 2/3 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	27.8% 10/36 • Number of events 10 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	28.6% 2/7 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	28.6% 2/7 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	42.9% 3/7 • Number of events 5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 3/18 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	8.3% 3/36 • Number of events 4 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	66.7% 2/3 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	28.6% 2/7 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Investigations Neutrophil count decreased	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	8.3% 3/36 • Number of events 4 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	28.6% 2/7 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Renal and urinary disorders Nocturia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
General disorders Oedema	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	22.2% 4/18 • Number of events 4 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
General disorders Oedema peripheral	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 3/18 • Number of events 4 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	8.3% 3/36 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	40.0% 2/5 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Oesophageal fistula	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Oesophagitis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Onychomycosis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Oral blood blister	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Oral candidiasis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Oral disorder	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Oral herpes	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Osteomyelitis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
General disorders Pain	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 3/18 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Musculoskeletal and connective tissue disorders Pain in jaw	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Palmar erythema	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Nervous system disorders Paraesthesia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Paraesthesia oral	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Cardiac disorders Pericardial effusion	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 1/1 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
General disorders Peripheral swelling	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	11.1% 2/18 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	28.6% 2/7 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Investigations Platelet count decreased	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 3/18 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	19.4% 7/36 • Number of events 8 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	42.9% 3/7 • Number of events 4 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 1/1 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Investigations Platelet count increased	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 1/1 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	11.1% 2/18 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Pneumonia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Injury, poisoning and procedural complications Procedural pain	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Investigations Prothrombin time prolonged	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 1/1 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
General disorders Pyrexia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 2/6 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 1/1 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Rhinitis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	11.1% 2/18 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	28.6% 2/7 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Cardiac disorders Tachycardia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 2/2 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 1/1 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Nervous system disorders Somnolence	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	8.3% 3/36 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	40.0% 2/5 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Injury, poisoning and procedural complications Subcutaneous haematoma	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Injury, poisoning and procedural complications Sunburn	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Injury, poisoning and procedural complications Synovial rupture	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Nervous system disorders Taste disorder	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	100.0% 3/3 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 6/18 • Number of events 9 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	22.2% 8/36 • Number of events 9 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	66.7% 2/3 • Number of events 5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	57.1% 4/7 • Number of events 5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	71.4% 5/7 • Number of events 12 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 3/6 • Number of events 6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Tongue haematoma	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	50.0% 1/2 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Toothache	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	2.8% 1/36 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Cardiac disorders Tricuspid valve incompetence	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Investigations Troponin I increased	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Investigations Troponin increased	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Urinary tract infection	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Infections and infestations Vascular device infection	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Eye disorders Vision blurred	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Eye disorders Vitreous floaters	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 2/6 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	38.9% 7/18 • Number of events 7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	13.9% 5/36 • Number of events 5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 1/3 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	14.3% 1/7 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	16.7% 1/6 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Investigations Weight decreased	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 2/6 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	11.1% 2/18 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	42.9% 3/7 • Number of events 3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	28.6% 2/7 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	33.3% 2/6 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 1/18 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/36 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/5 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
Investigations White blood cell count decreased	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/18 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	5.6% 2/36 • Number of events 4 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/3 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	28.6% 2/7 • Number of events 2 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	20.0% 1/5 • Number of events 1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/7 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/1 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.	0.00% 0/6 • up to 1387 days Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: medinfo@incyte.com

Results disclosure agreements

• Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
• Publication restrictions are in place

Restriction type: OTHER