Trial Outcomes & Findings for A Study of TAK-659 in Combination With Nivolumab in Participants With Advanced Solid Tumors (NCT NCT02834247)

NCT ID: NCT02834247

Last Updated: 2023-02-08

Results Overview

The MTD was defined as the dose range at which less than or equal to (\<=) 1 of 6 evaluable participants experience dose limiting toxicities (DLT) within the first 28 days of treatment (end of Cycle 1). Toxicities were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 41 participants
• Primary outcome timeframe: At end of Cycle 1 Day 28
• Results posted on: 2023-02-08

Participant Flow

Participants took part in the study at 13 investigative sites in the United States, Spain and United Kingdom from 12 August 2016 to 30 November 2018.

Participants with advanced solid tumors and metastatic TNBC were enrolled in Parts 1 and 2 respectively. Part 2 cohorts: TNBC cohort was discontinued due to insufficient efficacy of drug. Study was terminated before start of potential fixed dose cohort, non-small cell lung cancer cohort and head and neck squamous cell carcinoma cohort.

Participant milestones

Measure	Part 1: TAK-659 60 mg + Nivolumab 3 mg/kg TAK-659 60 milligram (mg), tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 milligram per kilogram (mg/kg), infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until progressive disease (PD) or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC) TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic triple negative breast cancer (TNBC).
Dose Escalation Phase STARTED	8	11	5	0
Dose Escalation Phase COMPLETED	0	0	0	0
Dose Escalation Phase NOT COMPLETED	8	11	5	0
Dose Expansion Phase STARTED	0	0	0	17
Dose Expansion Phase COMPLETED	0	0	0	0
Dose Expansion Phase NOT COMPLETED	0	0	0	17

Reasons for withdrawal

Measure	Part 1: TAK-659 60 mg + Nivolumab 3 mg/kg TAK-659 60 milligram (mg), tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 milligram per kilogram (mg/kg), infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until progressive disease (PD) or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC) TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic triple negative breast cancer (TNBC).
Dose Escalation Phase Study Terminated by Sponsor	1	2	0	0
Dose Escalation Phase Death	5	6	5	0
Dose Escalation Phase Lost to Follow-up	0	1	0	0
Dose Escalation Phase Withdrawal by Subject	2	2	0	0
Dose Expansion Phase Study Terminated by Sponsor	0	0	0	7
Dose Expansion Phase Death	0	0	0	8
Dose Expansion Phase Lost to Follow-up	0	0	0	1
Dose Expansion Phase Withdrawal by Subject	0	0	0	1

Baseline Characteristics

A Study of TAK-659 in Combination With Nivolumab in Participants With Advanced Solid Tumors

Baseline characteristics by cohort

Measure	Part 1: TAK-659 60 mg + Nivolumab 3 mg/kg n=8 Participants TAK-659 60 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg n=11 Participants TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg n=5 Participants TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC) n=17 Participants TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic TNBC.	Total n=41 Participants Total of all reporting groups
Age, Continuous	57.8 years STANDARD_DEVIATION 8.53 • n=5 Participants	51.2 years STANDARD_DEVIATION 16.04 • n=7 Participants	56.8 years STANDARD_DEVIATION 16.22 • n=5 Participants	49.2 years STANDARD_DEVIATION 8.62 • n=4 Participants	52.3 years STANDARD_DEVIATION 12.08 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	17 Participants n=4 Participants	32 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	9 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	10 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants	37 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants	32 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment Spain	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	9 Participants n=4 Participants	9 Participants n=21 Participants
Region of Enrollment United Kingdom	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment United States	8 Participants n=5 Participants	11 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	30 Participants n=21 Participants
Height	166.09 centimeter (cm) STANDARD_DEVIATION 11.473 • n=5 Participants	166.58 centimeter (cm) STANDARD_DEVIATION 11.360 • n=7 Participants	167.00 centimeter (cm) STANDARD_DEVIATION 5.523 • n=5 Participants	164.03 centimeter (cm) STANDARD_DEVIATION 8.245 • n=4 Participants	165.48 centimeter (cm) STANDARD_DEVIATION 9.334 • n=21 Participants
Weight	71.75 kilogram (kg) STANDARD_DEVIATION 19.006 • n=5 Participants	60.11 kilogram (kg) STANDARD_DEVIATION 17.393 • n=7 Participants	73.62 kilogram (kg) STANDARD_DEVIATION 13.646 • n=5 Participants	69.50 kilogram (kg) STANDARD_DEVIATION 12.266 • n=4 Participants	67.92 kilogram (kg) STANDARD_DEVIATION 15.572 • n=21 Participants

PRIMARY outcome

Timeframe: At end of Cycle 1 Day 28

Population: The DLT-evaluable population was defined as participants who had met the minimum treatment and safety evaluation requirements of the study and/or who experienced a DLT during Cycle 1.

The MTD was defined as the dose range at which less than or equal to (<=) 1 of 6 evaluable participants experience dose limiting toxicities (DLT) within the first 28 days of treatment (end of Cycle 1). Toxicities were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.

Outcome measures

Measure	Part 1: Dose Escalation Participants n=19 Participants TAK-659 60 mg, 80 mg or 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48).	Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC) TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic TNBC.
Part 1, Dose Escalation Phase: Maximum Tolerated Dose (MTD)	80 mg	—	—	—

PRIMARY outcome

Timeframe: Up to Cycle 12 (each Cycle length is equal to [=] 28 days)

Population: The DLT-evaluable population was defined as participants who had met the minimum treatment and safety evaluation requirements of the study and/or who experienced a DLT during Cycle 1.

RP2D was evaluated from cumulative toxicities in Cycle 1 and beyond. Toxicities were evaluated according to NCI CTCAE version 4.03.

Outcome measures

Measure	Part 1: Dose Escalation Participants n=19 Participants TAK-659 60 mg, 80 mg or 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48).	Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC) TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic TNBC.
Part 1, Dose Escalation Phase: Recommendation Phase 2 Dose (RP2D)	80 mg	—	—	—

PRIMARY outcome

Timeframe: From the start of study treatment until the start of subsequent anticancer therapy (up to 28 months)

Population: The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at Baseline, and had at least 1 post-baseline disease assessment.

ORR was defined as the percentage of participants who's best overall response (BOR) was either complete response (CR) or partial response (PR). The ORR assessment was based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The BOR was defined as the best response recorded from the start of the study treatment until the start of subsequent anticancer therapy. CR: was disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (<) 10 millimeter (mm). PR: was at least a 30 percent (%) decrease in sum of diameter (SOD) of target lesions, taking as reference the baseline SOD.

Outcome measures

Measure	Part 1: Dose Escalation Participants n=15 Participants TAK-659 60 mg, 80 mg or 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48).	Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC) TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic TNBC.
Part 2, Dose Expansion Phase: Overall Response Rate (ORR)	0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: From the first dose of the study drug up to 28 days after the last dose of the study drug or the start of subsequent anticancer therapy (up to 28 months)

Population: The safety population was defined as all the participants who received at least 1 dose of study drug.

AEs Grades were evaluated as per NCI CTCAE version 4.03.

Outcome measures

Measure	Part 1: Dose Escalation Participants n=8 Participants TAK-659 60 mg, 80 mg or 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48).	Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg n=11 Participants TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg n=5 Participants TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC) n=17 Participants TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic TNBC.
Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Events (TEAEs), Grade 3 or 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation TEAEs	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants
Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Events (TEAEs), Grade 3 or 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation Grade 3 or 4 AEs	87.5 percentage of participants	81.8 percentage of participants	100 percentage of participants	76.5 percentage of participants
Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Events (TEAEs), Grade 3 or 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation SAEs	75.0 percentage of participants	63.6 percentage of participants	80.0 percentage of participants	70.6 percentage of participants
Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Events (TEAEs), Grade 3 or 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation TEAEs Leading to Discontinuation	25.0 percentage of participants	27.3 percentage of participants	20.0 percentage of participants	23.5 percentage of participants

SECONDARY outcome

Timeframe: From the start of study treatment until the start of subsequent anticancer therapy (up to 28 months)

Population: The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at Baseline, and had at least 1 post-baseline disease assessment.

DCR was the percentage of participants who had BOR with either CR, PR, or stable disease (SD). The DCR assessment was based on RECIST version 1.1. The BOR was defined as the best response recorded from the start of the study treatment until the start of subsequent anticancer therapy. CR: was disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to <10 mm. PR: was at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD.

Outcome measures

Measure	Part 1: Dose Escalation Participants n=15 Participants TAK-659 60 mg, 80 mg or 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48).	Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC) TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic TNBC.
Part 2, Dose Expansion Phase: Disease Control Rate (DCR)	26.7 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: From the date of first documentation of a response to the date of first documented PD (up to 28 months)

Population: The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at Baseline, and had at least 1 post-baseline disease assessment.

DOR was defined as the time from the date of first documentation of a response to the date of first documented progressive disease. DOR assessment was based on RECIST v1.1. CR: was disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to <10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. DOR was calculated using Kaplan-Meier analysis.

Outcome measures

Measure	Part 1: Dose Escalation Participants n=15 Participants TAK-659 60 mg, 80 mg or 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48).	Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC) TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic TNBC.
Part 2, Dose Expansion Phase: Duration of Response (DOR)	NA months Median, lower and upper limit of confidence interval could not be calculated because no participant had an event.	—	—	—

SECONDARY outcome

Timeframe: Month 6

Population: The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at Baseline, and had at least 1 post-baseline disease assessment.

PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. The PD assessment was based on RECIST v1.1.

Outcome measures

Measure	Part 1: Dose Escalation Participants n=15 Participants TAK-659 60 mg, 80 mg or 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48).	Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC) TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic TNBC.
Part 2, Dose Expansion Phase: Percentage of Participants With PD at Month 6	86.7 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: From the date of first study drug administration up to date of first documented PD or death due to any cause, whichever occurred first (up to 28 months)

Population: The safety population was defined as all the participants who received at least 1 dose of study drug.

PFS was defined as the time from date of first study drug administration to the date of first documented PD or death due to any cause, whichever occurred first. The PFS assessment was based on RECIST v1.1. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was calculated using Kaplan-Meier estimate.

Outcome measures

Measure	Part 1: Dose Escalation Participants n=17 Participants TAK-659 60 mg, 80 mg or 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48).	Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC) TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic TNBC.
Part 2, Dose Expansion Phase: Progression Free Survival (PFS)	1.7 months Interval 1.0 to 2.8	—	—	—

SECONDARY outcome

Timeframe: Baseline up to the date of death due to any cause (up to 28 months)

Population: The safety population was defined as all the participants who received at least 1 dose of study drug.

OS was calculated from date of participant enrollment to the date of participant's death due to any cause. OS was assessed based on RECIST v 1.1. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier. OS was calculated using Kaplan-Meier estimate. Enrollment was defined as the time of the initiation of the first dose of study drug.

Outcome measures

Measure	Part 1: Dose Escalation Participants n=17 Participants TAK-659 60 mg, 80 mg or 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48).	Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC) TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic TNBC.
Part 2, Dose Expansion Phase: Overall Survival (OS)	4.9 months Interval 3.1 to Upper Limit of confidence interval could not be estimated due to insufficient number of events.	—	—	—

SECONDARY outcome

Timeframe: Cycle 1, Days 1 and 15: pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)

Population: The pharmacokinetic (PK)-evaluable population was defined as participants with sufficient concentration-time and dosing data to reliably estimate PK parameters. PK-evaluable population where data at specified time points was available.

Outcome measures

Measure	Part 1: Dose Escalation Participants n=8 Participants TAK-659 60 mg, 80 mg or 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48).	Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg n=11 Participants TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg n=5 Participants TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC) TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic TNBC.
Part 1, Dose Escalation Phase, Cmax: Maximum Observed Plasma Concentration for TAK-659 Cycle 1 Day 1	84.02 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 56.11	212.51 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 64.69	165.60 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 55.53	—
Part 1, Dose Escalation Phase, Cmax: Maximum Observed Plasma Concentration for TAK-659 Cycle 1 Day 15	132.04 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 67.98	236.08 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 58.99	379.82 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 26.66	—

SECONDARY outcome

Timeframe: Cycle 1, Days 1 and 15: pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)

Population: The PK-Evaluable population was defined as participants with sufficient concentration-time and dosing data to reliably estimate PK parameters. PK-evaluable population where data at specified time points was available.

Outcome measures

Measure	Part 1: Dose Escalation Participants n=8 Participants TAK-659 60 mg, 80 mg or 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48).	Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg n=11 Participants TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg n=5 Participants TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC) TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic TNBC.
Part 1, Dose Escalation Phase, Tmax: Time to Reach the Cmax for TAK-659 Cycle 1 Day 1	2.2000 hour Interval 0.417 to 7.5	2.0667 hour Interval 0.5 to 4.1	3.7000 hour Interval 0.9 to 4.05	—
Part 1, Dose Escalation Phase, Tmax: Time to Reach the Cmax for TAK-659 Cycle 1 Day 15	1.9833 hour Interval 1.117 to 4.033	3.8583 hour Interval 2.0 to 5.017	3.8333 hour Interval 2.05 to 3.967	—

SECONDARY outcome

Timeframe: Cycle 1, Days 1 and 15: pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)

Population: The PK-evaluable population was defined as participants with sufficient concentration-time and dosing data to reliably estimate PK parameters. PK-evaluable population where data at specified time points was available.

Outcome measures

Measure	Part 1: Dose Escalation Participants n=8 Participants TAK-659 60 mg, 80 mg or 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48).	Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg n=11 Participants TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg n=5 Participants TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC) TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic TNBC.
Part 1, Dose Escalation Phase, AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for Area Under the Plasma Concentration for TAK-659 Cycle 1 Day 1	845.7076 hour*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 24.5906	1867.3673 hour*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 59.4921	1745.0750 hour*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 56.3522	—
Part 1, Dose Escalation Phase, AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for Area Under the Plasma Concentration for TAK-659 Cycle 1 Day 15	1906.1855 hour*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 28.4065	2259.5453 hour*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 35.4104	4515.3938 hour*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 37.5764	—

Adverse Events

Part 1: TAK-659 60 mg + Nivolumab 3 mg/kg

Serious events: 6 serious events

Other events: 8 other events

Deaths: 5 deaths

Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg

Serious events: 7 serious events

Other events: 11 other events

Deaths: 6 deaths

Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg

Serious events: 4 serious events

Other events: 5 other events

Deaths: 5 deaths

Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC)

Serious events: 12 serious events

Other events: 17 other events

Deaths: 8 deaths

Serious adverse events

Measure	Part 1: TAK-659 60 mg + Nivolumab 3 mg/kg n=8 participants at risk TAK-659 60 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg n=11 participants at risk TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg n=5 participants at risk TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC) n=17 participants at risk TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic TNBC.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	17.6% 3/17 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
General disorders Pyrexia	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	23.5% 4/17 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
General disorders Fatigue	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Sepsis	25.0% 2/8 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Anal abscess	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Bacteraemia	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Device related infection	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Lung infection	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	11.8% 2/17 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Triple negative breast cancer	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Cardiac disorders Cardiac arrest	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Cardiac disorders Left ventricular dysfunction	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Cardiac disorders Myocarditis	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Metabolism and nutrition disorders Hyponatraemia	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Aphasia	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Headache	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Psychiatric disorders Confusional state	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Nausea	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Vomiting	12.5% 1/8 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Lipase increased	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Musculoskeletal and connective tissue disorders Back pain	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Platelet count decreased	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.

Other adverse events

Measure	Part 1: TAK-659 60 mg + Nivolumab 3 mg/kg n=8 participants at risk TAK-659 60 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg n=11 participants at risk TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg n=5 participants at risk TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.	Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC) n=17 participants at risk TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic TNBC.
Metabolism and nutrition disorders Hypophosphataemia	25.0% 2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	63.6% 7/11 • Number of events 21 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	23.5% 4/17 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Metabolism and nutrition disorders Hypokalaemia	25.0% 2/8 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	72.7% 8/11 • Number of events 13 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	17.6% 3/17 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Metabolism and nutrition disorders Decreased appetite	50.0% 4/8 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	23.5% 4/17 • Number of events 6 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Metabolism and nutrition disorders Hypocalcaemia	25.0% 2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	17.6% 3/17 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Metabolism and nutrition disorders Dehydration	25.0% 2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	27.3% 3/11 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	27.3% 3/11 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	11.8% 2/17 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Metabolism and nutrition disorders Hyponatraemia	25.0% 2/8 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	40.0% 2/5 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Metabolism and nutrition disorders Cachexia	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Metabolism and nutrition disorders Hypovolaemia	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Metabolism and nutrition disorders Lactic acidosis	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Metabolism and nutrition disorders Malnutrition	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Metabolism and nutrition disorders Polydipsia	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
General disorders Fatigue	62.5% 5/8 • Number of events 9 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	36.4% 4/11 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	60.0% 3/5 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	29.4% 5/17 • Number of events 7 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
General disorders Pyrexia	25.0% 2/8 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	27.3% 3/11 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	40.0% 2/5 • Number of events 6 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	35.3% 6/17 • Number of events 8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
General disorders Oedema peripheral	37.5% 3/8 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	29.4% 5/17 • Number of events 6 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
General disorders Asthenia	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
General disorders Chills	25.0% 2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
General disorders Early satiety	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
General disorders Face oedema	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	11.8% 2/17 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
General disorders Pain	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
General disorders Chest discomfort	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
General disorders Chest pain	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
General disorders Gait disturbance	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
General disorders Generalised oedema	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
General disorders Malaise	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Aspartate aminotransferase increased	25.0% 2/8 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	54.5% 6/11 • Number of events 16 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	80.0% 4/5 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	41.2% 7/17 • Number of events 10 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Alanine aminotransferase increased	25.0% 2/8 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	54.5% 6/11 • Number of events 10 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	60.0% 3/5 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	29.4% 5/17 • Number of events 6 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Amylase increased	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	54.5% 6/11 • Number of events 12 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	60.0% 3/5 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	23.5% 4/17 • Number of events 6 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Lipase increased	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	45.5% 5/11 • Number of events 9 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	60.0% 3/5 • Number of events 7 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Blood creatine phosphokinase increased	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	47.1% 8/17 • Number of events 13 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Troponin increased	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	27.3% 3/11 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Weight decreased	25.0% 2/8 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Blood alkaline phosphatase increased	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Lymphocyte count decreased	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Platelet count decreased	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	40.0% 2/5 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Blood glucose increased	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Blood lactate dehydrogenase increased	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	11.8% 2/17 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Electrocardiogram QT prolonged	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Electrocardiogram ST-T segment abnormal	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Gamma-glutamyltransferase increased	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Weight increased	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Bacterial test positive	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Blood bilirubin increased	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Blood corticotrophin decreased	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Blood creatinine increased	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Cardiac murmur	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Electrocardiogram T wave abnormal	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Protein urine	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Respiratory syncytial virus test positive	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Transferrin saturation decreased	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Investigations Troponin T increased	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Diarrhoea	50.0% 4/8 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	54.5% 6/11 • Number of events 9 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	40.0% 2/5 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	35.3% 6/17 • Number of events 6 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Nausea	62.5% 5/8 • Number of events 7 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	23.5% 4/17 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Constipation	25.0% 2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	36.4% 4/11 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	23.5% 4/17 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Vomiting	50.0% 4/8 • Number of events 9 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	36.4% 4/11 • Number of events 6 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Dry mouth	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	11.8% 2/17 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Stomatitis	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	40.0% 2/5 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Abdominal distension	25.0% 2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Ascites	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Abdominal discomfort	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Oral pain	25.0% 2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Angular cheilitis	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Dyspepsia	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Dysphagia	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Gastric dilatation	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Glossodynia	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Melaena	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Oesophagitis	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Tooth disorder	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Gastrointestinal disorders Toothache	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Urinary tract infection	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Candida infection	12.5% 1/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	11.8% 2/17 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Oral candidiasis	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Upper respiratory tract infection	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Lower respiratory tract infection	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	11.8% 2/17 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Pneumonia	25.0% 2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Abscess	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Anal abscess	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Bacteriuria	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Clostridium difficile infection	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Conjunctivitis	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Device related infection	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Lymphangitis	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Oropharyngeal candidiasis	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Pneumonia cytomegaloviral	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Respiratory tract infection	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Rhinitis	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Rhinovirus infection	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Tooth abscess	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Infections and infestations Wound infection	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	37.5% 3/8 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	45.5% 5/11 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	52.9% 9/17 • Number of events 9 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Cough	37.5% 3/8 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	54.5% 6/11 • Number of events 7 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	17.6% 3/17 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	25.0% 2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Dysphonia	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Respiratory tract oedema	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Headache	25.0% 2/8 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	23.5% 4/17 • Number of events 7 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Dizziness	37.5% 3/8 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	17.6% 3/17 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Dysgeusia	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	40.0% 2/5 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Hypoaesthesia	25.0% 2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Balance disorder	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Neuropathy peripheral	25.0% 2/8 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Ataxia	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Drooling	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Encephalopathy	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Migraine	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Motor dysfunction	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Paraesthesia	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Peripheral motor neuropathy	12.5% 1/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Peripheral sensory neuropathy	12.5% 1/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Resting tremor	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Restless legs syndrome	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Sinus headache	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Somnolence	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Nervous system disorders Vocal cord paralysis	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Blood and lymphatic system disorders Anaemia	37.5% 3/8 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	54.5% 6/11 • Number of events 9 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	40.0% 2/5 • Number of events 7 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	23.5% 4/17 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Blood and lymphatic system disorders Neutropenia	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Musculoskeletal and connective tissue disorders Back pain	37.5% 3/8 • Number of events 6 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	17.6% 3/17 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Musculoskeletal and connective tissue disorders Myalgia	25.0% 2/8 • Number of events 6 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	17.6% 3/17 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	25.0% 2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	11.8% 2/17 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	11.8% 2/17 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 1/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	25.0% 2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Musculoskeletal and connective tissue disorders Groin pain	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Musculoskeletal and connective tissue disorders Pain in jaw	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Skin and subcutaneous tissue disorders Rash	25.0% 2/8 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	40.0% 2/5 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	23.5% 4/17 • Number of events 12 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Skin and subcutaneous tissue disorders Ecchymosis	25.0% 2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	11.8% 2/17 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Skin and subcutaneous tissue disorders Rash pruritic	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Skin and subcutaneous tissue disorders Swelling face	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Skin and subcutaneous tissue disorders Alopecia	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Skin and subcutaneous tissue disorders Decubitus ulcer	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Skin and subcutaneous tissue disorders Dry skin	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Cardiac disorders Tachycardia	37.5% 3/8 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	17.6% 3/17 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Cardiac disorders Sinus tachycardia	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Cardiac disorders Acute myocardial infarction	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Cardiac disorders Extrasystoles	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Cardiac disorders Left ventricular failure	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Cardiac disorders Left ventricular hypertrophy	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Cardiac disorders Ventricular hypokinesia	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Eye disorders Periorbital oedema	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	27.3% 3/11 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Eye disorders Dry eye	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Eye disorders Vitreous floaters	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Eye disorders Cataract	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Eye disorders Exophthalmos	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Eye disorders Eye swelling	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Eye disorders Photophobia	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Eye disorders Photopsia	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Eye disorders Uveitis	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Eye disorders Vitreous degeneration	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Injury, poisoning and procedural complications Fall	37.5% 3/8 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Injury, poisoning and procedural complications Contusion	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Injury, poisoning and procedural complications Allergic transfusion reaction	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Injury, poisoning and procedural complications Limb injury	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Injury, poisoning and procedural complications Skin abrasion	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Psychiatric disorders Confusional state	25.0% 2/8 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Psychiatric disorders Depression	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	18.2% 2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Psychiatric disorders Anxiety	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Psychiatric disorders Insomnia	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Psychiatric disorders Irritability	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Psychiatric disorders Mental status changes	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Vascular disorders Hypotension	25.0% 2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Vascular disorders Flushing	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Vascular disorders Deep vein thrombosis	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Vascular disorders Hot flush	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Vascular disorders Hypertension	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Vascular disorders Lymphoedema	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Renal and urinary disorders Acute kidney injury	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Renal and urinary disorders Dysuria	25.0% 2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Renal and urinary disorders Polyuria	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Renal and urinary disorders Proteinuria	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Renal and urinary disorders Urinary incontinence	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Hepatobiliary disorders Hepatomegaly	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Reproductive system and breast disorders Breast discomfort	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Reproductive system and breast disorders Breast pain	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Reproductive system and breast disorders Testicular oedema	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	9.1% 1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Ear and labyrinth disorders Tinnitus	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	5.9% 1/17 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Ear and labyrinth disorders Ear pain	12.5% 1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/5 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.
Endocrine disorders Adrenal insufficiency	0.00% 0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	20.0% 1/5 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.	0.00% 0/17 • TEAEs are AEs that started after the first dose of study drug and no more than 28 days after the last dose of study drug (up to 28 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 28 days after the last dose of the study drug.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: trialdisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
• Publication restrictions are in place

Restriction type: OTHER