Trial Outcomes & Findings for A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment (NCT NCT01610336)

Last Updated: 2021-04-08

Results Overview

A dose-limiting toxicity (DLT) was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

161 participants

Primary outcome timeframe

Up to 215 weeks

Results posted on

2021-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	INC280 100 mg Cap QD Phase Ib cap=capsule; QD=once daily	INC280 200 mg Cap QD Phase Ib cap=capsule; QD=once daily	INC280 400 mg Cap QD Phase Ib cap=capsule; QD=once daily	INC280 800 mg Cap QD Phase Ib cap=capsule; QD=once daily	INC280 200 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 400 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 600 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 200 mg Tab BID Phase Ib tab=tablet; BID=twice daily	INC280 400 mg Tab BID Phase Ib tab=tablet; BID=twice daily	INC280 400 mg Cap BID Phase II cap=capsule; BID=twice daily	INC280 400 mg Tab BID Phase II tab=tablet; BID=twice daily
Overall Study STARTED	5	7	6	7	4	12	5	7	8	53	47
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	5	7	6	7	4	12	5	7	8	53	47

Reasons for withdrawal

Reasons for withdrawal
Measure	INC280 100 mg Cap QD Phase Ib cap=capsule; QD=once daily	INC280 200 mg Cap QD Phase Ib cap=capsule; QD=once daily	INC280 400 mg Cap QD Phase Ib cap=capsule; QD=once daily	INC280 800 mg Cap QD Phase Ib cap=capsule; QD=once daily	INC280 200 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 400 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 600 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 200 mg Tab BID Phase Ib tab=tablet; BID=twice daily	INC280 400 mg Tab BID Phase Ib tab=tablet; BID=twice daily	INC280 400 mg Cap BID Phase II cap=capsule; BID=twice daily	INC280 400 mg Tab BID Phase II tab=tablet; BID=twice daily
Overall Study Adverse Event	0	0	0	1	1	1	0	0	2	8	6
Overall Study Subject/Guardian decision	1	1	0	1	0	0	0	1	0	2	2
Overall Study Progressive Disease	4	6	6	5	3	10	1	6	6	40	36
Overall Study Death	0	0	0	0	0	1	3	0	0	1	2
Overall Study Non-Compliance with study treatment	0	0	0	0	0	0	0	0	0	1	0
Overall Study Physician Decision	0	0	0	0	0	0	1	0	0	0	0
Overall Study Protocol Deviation	0	0	0	0	0	0	0	0	0	1	0
Overall Study Transfer to another trial	0	0	0	0	0	0	0	0	0	0	1

Baseline Characteristics

A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INC280 100 mg Cap QD Phase Ib n=5 Participants cap=capsule; QD=once daily	INC280 200 mg Cap QD Phase Ib n=7 Participants cap=capsule; QD=once daily	INC280 400 mg Cap QD Phase Ib n=6 Participants cap=capsule; QD=once daily	INC280 800 mg Cap QD Phase Ib n=7 Participants cap=capsule; QD=once daily	INC280 200 mg Cap BID Phase Ib n=4 Participants cap=capsule; BID=twice daily	INC280 400 mg Cap BID Phase Ib n=12 Participants cap=capsule; BID=twice daily	INC280 600 mg Cap BID Phase Ib n=5 Participants cap=capsule; BID=twice daily	INC280 200 mg Tab BID Phase Ib n=7 Participants tab=tablet; BID=twice daily	INC280 400 mg Tab BID Phase Ib n=8 Participants tab=tablet; BID=twice daily	INC280 400 mg Cap BID Phase II n=53 Participants cap=capsule; BID=twice daily	INC280 400 mg Tab BID Phase II n=47 Participants tab=tablet; BID=twice daily	Total n=161 Participants Total of all reporting groups
Age, Continuous	57.8 years STANDARD_DEVIATION 11.05 • n=5 Participants	60.4 years STANDARD_DEVIATION 15.27 • n=7 Participants	59.5 years STANDARD_DEVIATION 6.89 • n=5 Participants	51.3 years STANDARD_DEVIATION 8.88 • n=4 Participants	64.5 years STANDARD_DEVIATION 8.89 • n=21 Participants	55.9 years STANDARD_DEVIATION 10.81 • n=8 Participants	61.0 years STANDARD_DEVIATION 8.46 • n=8 Participants	60.9 years STANDARD_DEVIATION 12.86 • n=24 Participants	58.4 years STANDARD_DEVIATION 5.01 • n=42 Participants	58.6 years STANDARD_DEVIATION 10.50 • n=42 Participants	62.8 years STANDARD_DEVIATION 9.32 • n=42 Participants	59.7 years STANDARD_DEVIATION 10.20 • n=42 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=8 Participants	2 Participants n=8 Participants	5 Participants n=24 Participants	5 Participants n=42 Participants	33 Participants n=42 Participants	19 Participants n=42 Participants	88 Participants n=42 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	8 Participants n=8 Participants	3 Participants n=8 Participants	2 Participants n=24 Participants	3 Participants n=42 Participants	20 Participants n=42 Participants	28 Participants n=42 Participants	73 Participants n=42 Participants
Race/Ethnicity, Customized Russian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Mixed Ethnicity	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Not reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants
Race/Ethnicity, Customized Hispanic or Latino	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	1 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	5 Participants n=42 Participants	7 Participants n=42 Participants
Race/Ethnicity, Customized Southeast Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	8 Participants n=42 Participants	12 Participants n=42 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	11 Participants n=42 Participants	17 Participants n=42 Participants
Race/Ethnicity, Customized East Asian	4 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	3 Participants n=21 Participants	9 Participants n=8 Participants	4 Participants n=8 Participants	3 Participants n=24 Participants	7 Participants n=42 Participants	53 Participants n=42 Participants	16 Participants n=42 Participants	118 Participants n=42 Participants

PRIMARY outcome

Timeframe: Up to 215 weeks

Population: Safety Set: All patients in phase Ib who received at least one full or partial dose of INC280 or gefitinib.

Outcome measures

Outcome measures
Measure	INC280 100 mg Cap QD Phase Ib n=3 Participants cap=capsule; QD=once daily	INC280 200 mg Cap QD Phase Ib n=7 Participants cap=capsule; QD=once daily	INC280 400 mg Cap QD Phase Ib n=6 Participants cap=capsule; QD=once daily	INC280 800 mg Cap QD Phase Ib n=5 Participants cap=capsule; QD=once daily	INC280 200 mg Cap BID Phase Ib n=4 Participants cap=capsule; BID=twice daily	INC280 400 mg Cap BID Phase Ib n=10 Participants cap=capsule; BID=twice daily	INC280 600 mg Cap BID Phase Ib n=1 Participants cap=capsule; BID=twice daily	INC280 200 mg Tab BID Phase Ib n=7 Participants tab=tablet; BID=twice daily	INC280 400 mg Tab BID Phase Ib n=7 Participants tab=tablet; BID=twice daily	INC280 400 mg Cap BID Phase II cap=capsule; BID=twice daily	INC280 400 mg Tab BID Phase II tab=tablet; BID=twice daily
Phase Ib: Frequency of Dose Limiting Toxicities (DLTs) Cough	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—
Phase Ib: Frequency of Dose Limiting Toxicities (DLTs) Dizziness	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase Ib: Frequency of Dose Limiting Toxicities (DLTs) Dyspnoea	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: Until disease progression, up to 60.8 weeks

Population: Full analysis set: all patients in phase II who receive at least one full or partial dose of INC280 or gefitinib.

Overall response rate is defined as the proportion of patients with best overall response (BOR) of complete response (CR) or partial response (PR), as per RECIST 1.1 (Overall Response (OR) = CR + PR). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	INC280 100 mg Cap QD Phase Ib n=53 Participants cap=capsule; QD=once daily	INC280 200 mg Cap QD Phase Ib n=47 Participants cap=capsule; QD=once daily	INC280 400 mg Cap QD Phase Ib cap=capsule; QD=once daily	INC280 800 mg Cap QD Phase Ib cap=capsule; QD=once daily	INC280 200 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 400 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 600 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 200 mg Tab BID Phase Ib tab=tablet; BID=twice daily	INC280 400 mg Tab BID Phase Ib tab=tablet; BID=twice daily	INC280 400 mg Cap BID Phase II cap=capsule; BID=twice daily	INC280 400 mg Tab BID Phase II tab=tablet; BID=twice daily
Phase II : Overall Response Rate (ORR)	12 Participants	17 Participants	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 421 weeks

Population: Safety Set: All patients in phase Ib and II who received at least one full or partial dose of INC280 or gefitinib and and had at least one valid postbaseline safety assessment.

Adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Outcome measures

Outcome measures
Measure	INC280 100 mg Cap QD Phase Ib n=5 Participants cap=capsule; QD=once daily	INC280 200 mg Cap QD Phase Ib n=7 Participants cap=capsule; QD=once daily	INC280 400 mg Cap QD Phase Ib n=6 Participants cap=capsule; QD=once daily	INC280 800 mg Cap QD Phase Ib n=7 Participants cap=capsule; QD=once daily	INC280 200 mg Cap BID Phase Ib n=4 Participants cap=capsule; BID=twice daily	INC280 400 mg Cap BID Phase Ib n=12 Participants cap=capsule; BID=twice daily	INC280 600 mg Cap BID Phase Ib n=5 Participants cap=capsule; BID=twice daily	INC280 200 mg Tab BID Phase Ib n=7 Participants tab=tablet; BID=twice daily	INC280 400 mg Tab BID Phase Ib n=8 Participants tab=tablet; BID=twice daily	INC280 400 mg Cap BID Phase II n=53 Participants cap=capsule; BID=twice daily	INC280 400 mg Tab BID Phase II n=47 Participants tab=tablet; BID=twice daily
Phase Ib and II: Number of Participants With Adverse Events (AEs) AEs	5 Participants	7 Participants	6 Participants	7 Participants	4 Participants	12 Participants	5 Participants	7 Participants	8 Participants	51 Participants	47 Participants
Phase Ib and II: Number of Participants With Adverse Events (AEs) Grade 3/4 AEs	3 Participants	4 Participants	2 Participants	4 Participants	2 Participants	6 Participants	4 Participants	6 Participants	4 Participants	24 Participants	35 Participants

SECONDARY outcome

Timeframe: Up to 421 weeks

Population: Safety Set: All patients in phase Ib and II who received at least one full or partial dose of INC280 or gefitinib and and had at least one valid postbaseline safety assessment.

Serious adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Outcome measures

Outcome measures
Measure	INC280 100 mg Cap QD Phase Ib n=5 Participants cap=capsule; QD=once daily	INC280 200 mg Cap QD Phase Ib n=7 Participants cap=capsule; QD=once daily	INC280 400 mg Cap QD Phase Ib n=6 Participants cap=capsule; QD=once daily	INC280 800 mg Cap QD Phase Ib n=7 Participants cap=capsule; QD=once daily	INC280 200 mg Cap BID Phase Ib n=4 Participants cap=capsule; BID=twice daily	INC280 400 mg Cap BID Phase Ib n=12 Participants cap=capsule; BID=twice daily	INC280 600 mg Cap BID Phase Ib n=5 Participants cap=capsule; BID=twice daily	INC280 200 mg Tab BID Phase Ib n=7 Participants tab=tablet; BID=twice daily	INC280 400 mg Tab BID Phase Ib n=8 Participants tab=tablet; BID=twice daily	INC280 400 mg Cap BID Phase II n=53 Participants cap=capsule; BID=twice daily	INC280 400 mg Tab BID Phase II n=47 Participants tab=tablet; BID=twice daily
Phase Ib and II: Number of Participants With Serious Adverse Events (SAEs)	1 Participants	2 Participants	2 Participants	3 Participants	0 Participants	4 Participants	3 Participants	5 Participants	3 Participants	12 Participants	19 Participants

SECONDARY outcome

Timeframe: Up to 417 weeks

Population: Safety Set: All patients in phase Ib and II who received at least one full or partial dose of INC280 or gefitinib.

Number of patients with dose reductions of INC280 by dose level as a measure of tolerability.

Outcome measures

Outcome measures
Measure	INC280 100 mg Cap QD Phase Ib n=5 Participants cap=capsule; QD=once daily	INC280 200 mg Cap QD Phase Ib n=7 Participants cap=capsule; QD=once daily	INC280 400 mg Cap QD Phase Ib n=6 Participants cap=capsule; QD=once daily	INC280 800 mg Cap QD Phase Ib n=7 Participants cap=capsule; QD=once daily	INC280 200 mg Cap BID Phase Ib n=4 Participants cap=capsule; BID=twice daily	INC280 400 mg Cap BID Phase Ib n=12 Participants cap=capsule; BID=twice daily	INC280 600 mg Cap BID Phase Ib n=5 Participants cap=capsule; BID=twice daily	INC280 200 mg Tab BID Phase Ib n=7 Participants tab=tablet; BID=twice daily	INC280 400 mg Tab BID Phase Ib n=8 Participants tab=tablet; BID=twice daily	INC280 400 mg Cap BID Phase II n=53 Participants cap=capsule; BID=twice daily	INC280 400 mg Tab BID Phase II n=47 Participants tab=tablet; BID=twice daily
Phase Ib and II: Number of Patients With Dose Reductions of INC280 by Dose Level Without dose reductions	5 Participants	6 Participants	5 Participants	6 Participants	1 Participants	8 Participants	1 Participants	5 Participants	5 Participants	30 Participants	23 Participants
Phase Ib and II: Number of Patients With Dose Reductions of INC280 by Dose Level Only 1 dose reduction	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	2 Participants	2 Participants	0 Participants	1 Participants	13 Participants	17 Participants
Phase Ib and II: Number of Patients With Dose Reductions of INC280 by Dose Level 2 dose reductions	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	6 Participants	5 Participants
Phase Ib and II: Number of Patients With Dose Reductions of INC280 by Dose Level 3 dose reductions	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Phase Ib and II: Number of Patients With Dose Reductions of INC280 by Dose Level >3 dose reductions	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 417 weeks

Population: Safety set: All patients in phase Ib and II who received at least one full or partial dose of INC280 or gefitinib.

Number of patients with dose interruptions of gefitinib by dose level as a measure of tolerability

Outcome measures

Outcome measures
Measure	INC280 100 mg Cap QD Phase Ib n=5 Participants cap=capsule; QD=once daily	INC280 200 mg Cap QD Phase Ib n=7 Participants cap=capsule; QD=once daily	INC280 400 mg Cap QD Phase Ib n=6 Participants cap=capsule; QD=once daily	INC280 800 mg Cap QD Phase Ib n=7 Participants cap=capsule; QD=once daily	INC280 200 mg Cap BID Phase Ib n=4 Participants cap=capsule; BID=twice daily	INC280 400 mg Cap BID Phase Ib n=12 Participants cap=capsule; BID=twice daily	INC280 600 mg Cap BID Phase Ib n=5 Participants cap=capsule; BID=twice daily	INC280 200 mg Tab BID Phase Ib n=7 Participants tab=tablet; BID=twice daily	INC280 400 mg Tab BID Phase Ib n=8 Participants tab=tablet; BID=twice daily	INC280 400 mg Cap BID Phase II n=53 Participants cap=capsule; BID=twice daily	INC280 400 mg Tab BID Phase II n=47 Participants tab=tablet; BID=twice daily
Phase Ib and II: Number of Patients With Dose Interruptions of Gefitinib by Dose Level Without dose interruptions	5 Participants	5 Participants	6 Participants	4 Participants	4 Participants	6 Participants	4 Participants	4 Participants	4 Participants	42 Participants	25 Participants
Phase Ib and II: Number of Patients With Dose Interruptions of Gefitinib by Dose Level With only one dose interruption	0 Participants	2 Participants	0 Participants	2 Participants	0 Participants	3 Participants	0 Participants	0 Participants	2 Participants	9 Participants	16 Participants
Phase Ib and II: Number of Patients With Dose Interruptions of Gefitinib by Dose Level 2 dose interruptions	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	4 Participants
Phase Ib and II: Number of Patients With Dose Interruptions of Gefitinib by Dose Level 3 dose interruptions	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Phase Ib and II: Number of Patients With Dose Interruptions of Gefitinib by Dose Level >3 dose interruptions	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From date of treatment until death due to any cause, up to 70.2 months

Population: Full analysis set: all patients in phase II who receive at least one full or partial dose of INC280 or gefitinib.

Overall survival is defined as the time from the start of treatment date to the date of death, due to any cause

Outcome measures

Outcome measures
Measure	INC280 100 mg Cap QD Phase Ib n=53 Participants cap=capsule; QD=once daily	INC280 200 mg Cap QD Phase Ib n=47 Participants cap=capsule; QD=once daily	INC280 400 mg Cap QD Phase Ib cap=capsule; QD=once daily	INC280 800 mg Cap QD Phase Ib cap=capsule; QD=once daily	INC280 200 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 400 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 600 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 200 mg Tab BID Phase Ib tab=tablet; BID=twice daily	INC280 400 mg Tab BID Phase Ib tab=tablet; BID=twice daily	INC280 400 mg Cap BID Phase II cap=capsule; BID=twice daily	INC280 400 mg Tab BID Phase II tab=tablet; BID=twice daily
Phase II: Overall Survival (OS)	12.3 Months Interval 8.1 to 15.4	15.2 Months Interval 11.7 to 20.1	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 60.8 months

Population: Full analysis set: all patients in phase II who receive at least one full or partial dose of INC280 or gefitinib

Progression-free survivalis the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause.

Outcome measures

Outcome measures
Measure	INC280 100 mg Cap QD Phase Ib n=53 Participants cap=capsule; QD=once daily	INC280 200 mg Cap QD Phase Ib n=47 Participants cap=capsule; QD=once daily	INC280 400 mg Cap QD Phase Ib cap=capsule; QD=once daily	INC280 800 mg Cap QD Phase Ib cap=capsule; QD=once daily	INC280 200 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 400 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 600 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 200 mg Tab BID Phase Ib tab=tablet; BID=twice daily	INC280 400 mg Tab BID Phase Ib tab=tablet; BID=twice daily	INC280 400 mg Cap BID Phase II cap=capsule; BID=twice daily	INC280 400 mg Tab BID Phase II tab=tablet; BID=twice daily
Phase II: Progression Free Survival (PFS)	5.1 Months Interval 3.6 to 5.6	5.5 Months Interval 3.8 to 7.3	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 23.2 months

Population: Full analysis set subjects in phase II with confirmed complete response (CR) or partial response (PR)

Duration of overall response (DOR) is defined as the time between the date of first documented response (CR or PR) and the date of first documented disease progression or death due to underlying cancer.

Outcome measures

Outcome measures
Measure	INC280 100 mg Cap QD Phase Ib n=12 Participants cap=capsule; QD=once daily	INC280 200 mg Cap QD Phase Ib n=17 Participants cap=capsule; QD=once daily	INC280 400 mg Cap QD Phase Ib cap=capsule; QD=once daily	INC280 800 mg Cap QD Phase Ib cap=capsule; QD=once daily	INC280 200 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 400 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 600 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 200 mg Tab BID Phase Ib tab=tablet; BID=twice daily	INC280 400 mg Tab BID Phase Ib tab=tablet; BID=twice daily	INC280 400 mg Cap BID Phase II cap=capsule; BID=twice daily	INC280 400 mg Tab BID Phase II tab=tablet; BID=twice daily
Phase II: Duration of Response (DoR)	5.6 Months Interval 3.7 to 6.2	5.6 Months Interval 3.7 to 7.4	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose) (Cycle=28 days)

Population: Pharmacokinetic analysis set: all patients having at least one evaluable PK profile of INC280 and/or gefitinib. Patients were included on the estimation of this PK parameter if a sufficient number of blood samples was available.

PK parameters were estimated from each individual plasma concentration-time profile using non-compartmental analysis. Area under the plasma concentration-time curve (AUC) from time zero to the end of dosing interval at steady state (tau), where tau=24 hours for once daily dosing and tau=12 hours for twice daily dosing

Outcome measures

Outcome measures
Measure	INC280 100 mg Cap QD Phase Ib n=4 Participants cap=capsule; QD=once daily	INC280 200 mg Cap QD Phase Ib n=7 Participants cap=capsule; QD=once daily	INC280 400 mg Cap QD Phase Ib n=5 Participants cap=capsule; QD=once daily	INC280 800 mg Cap QD Phase Ib n=3 Participants cap=capsule; QD=once daily	INC280 200 mg Cap BID Phase Ib n=4 Participants cap=capsule; BID=twice daily	INC280 400 mg Cap BID Phase Ib n=10 Participants cap=capsule; BID=twice daily	INC280 600 mg Cap BID Phase Ib n=2 Participants cap=capsule; BID=twice daily	INC280 200 mg Tab BID Phase Ib n=7 Participants tab=tablet; BID=twice daily	INC280 400 mg Tab BID Phase Ib n=7 Participants tab=tablet; BID=twice daily	INC280 400 mg Cap BID Phase II cap=capsule; BID=twice daily	INC280 400 mg Tab BID Phase II tab=tablet; BID=twice daily
Phase I: PK Parameters AUCtau of INC280 and Gefitinib INC280	4510 hr∙ng/mL Standard Deviation 1960	9140 hr∙ng/mL Standard Deviation 5550	29200 hr∙ng/mL Standard Deviation 12700	30300 hr∙ng/mL Standard Deviation 19800	9660 hr∙ng/mL Standard Deviation 5780	21400 hr∙ng/mL Standard Deviation 8420	37300 hr∙ng/mL Standard Deviation 18800	13900 hr∙ng/mL Standard Deviation 4470	28700 hr∙ng/mL Standard Deviation 5460	—	—
Phase I: PK Parameters AUCtau of INC280 and Gefitinib Gefitinib	7690 hr∙ng/mL Standard Deviation 1400	8070 hr∙ng/mL Standard Deviation 2080	7140 hr∙ng/mL Standard Deviation 1830	12800 hr∙ng/mL	8440 hr∙ng/mL Standard Deviation 2360	8500 hr∙ng/mL Standard Deviation 5330	—	7160 hr∙ng/mL Standard Deviation 2040	7820 hr∙ng/mL Standard Deviation 1130	—	—

SECONDARY outcome

Timeframe: Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose) (Cycle=28 days)

PK parameters were estimated from each individual plasma concentration-time profile using non-compartmental analysis. Cmax is the maximum observed plasma concentration of INC280 and gefitinib

Outcome measures

Outcome measures
Measure	INC280 100 mg Cap QD Phase Ib n=4 Participants cap=capsule; QD=once daily	INC280 200 mg Cap QD Phase Ib n=7 Participants cap=capsule; QD=once daily	INC280 400 mg Cap QD Phase Ib n=6 Participants cap=capsule; QD=once daily	INC280 800 mg Cap QD Phase Ib n=4 Participants cap=capsule; QD=once daily	INC280 200 mg Cap BID Phase Ib n=4 Participants cap=capsule; BID=twice daily	INC280 400 mg Cap BID Phase Ib n=10 Participants cap=capsule; BID=twice daily	INC280 600 mg Cap BID Phase Ib n=2 Participants cap=capsule; BID=twice daily	INC280 200 mg Tab BID Phase Ib n=7 Participants tab=tablet; BID=twice daily	INC280 400 mg Tab BID Phase Ib n=7 Participants tab=tablet; BID=twice daily	INC280 400 mg Cap BID Phase II cap=capsule; BID=twice daily	INC280 400 mg Tab BID Phase II tab=tablet; BID=twice daily
Phase I: PK Parameters Cmax of INC280 and Gefitinib INC280	826 ng/mL Standard Deviation 521	1490 ng/mL Standard Deviation 1430	4620 ng/mL Standard Deviation 3060	6570 ng/mL Standard Deviation 4360	1950 ng/mL Standard Deviation 985	4220 ng/mL Standard Deviation 2100	4840 ng/mL Standard Deviation 1990	2550 ng/mL Standard Deviation 676	6760 ng/mL Standard Deviation 1740	—	—
Phase I: PK Parameters Cmax of INC280 and Gefitinib Gefitinib	417 ng/mL Standard Deviation 42.9	378 ng/mL Standard Deviation 85.2	405 ng/mL Standard Deviation 144	357 ng/mL Standard Deviation 225	480 ng/mL Standard Deviation 191	464 ng/mL Standard Deviation 209	255 ng/mL Standard Deviation 158	479 ng/mL Standard Deviation 167	355 ng/mL Standard Deviation 74.1	—	—

SECONDARY outcome

Timeframe: Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose) (Cycle=28 days)

PK parameters were estimated from each individual plasma concentration-time profile using non-compartmental analysis. Tmax is the time to reach maximum plasma concentration of INC280 and gefitinib

Outcome measures

Outcome measures
Measure	INC280 100 mg Cap QD Phase Ib n=4 Participants cap=capsule; QD=once daily	INC280 200 mg Cap QD Phase Ib n=7 Participants cap=capsule; QD=once daily	INC280 400 mg Cap QD Phase Ib n=6 Participants cap=capsule; QD=once daily	INC280 800 mg Cap QD Phase Ib n=4 Participants cap=capsule; QD=once daily	INC280 200 mg Cap BID Phase Ib n=4 Participants cap=capsule; BID=twice daily	INC280 400 mg Cap BID Phase Ib n=10 Participants cap=capsule; BID=twice daily	INC280 600 mg Cap BID Phase Ib n=2 Participants cap=capsule; BID=twice daily	INC280 200 mg Tab BID Phase Ib n=7 Participants tab=tablet; BID=twice daily	INC280 400 mg Tab BID Phase Ib n=7 Participants tab=tablet; BID=twice daily	INC280 400 mg Cap BID Phase II cap=capsule; BID=twice daily	INC280 400 mg Tab BID Phase II tab=tablet; BID=twice daily
Phase I: PK Parameters Tmax of INC280 and Gefitinib INC280	1.96 Hours Interval 1.5 to 3.92	2.00 Hours Interval 1.0 to 24.0	2.00 Hours Interval 1.98 to 6.0	2.05 Hours Interval 1.92 to 5.97	1.50 Hours Interval 1.0 to 3.98	2.00 Hours Interval 0.5 to 4.0	5.00 Hours Interval 4.0 to 6.0	2.00 Hours Interval 1.0 to 4.0	1.08 Hours Interval 1.0 to 4.0	—	—
Phase I: PK Parameters Tmax of INC280 and Gefitinib Gefitinib	3.92 Hours Interval 0.0 to 8.0	6.00 Hours Interval 3.97 to 24.0	6.02 Hours Interval 2.0 to 8.0	5.94 Hours Interval 2.1 to 7.28	5.00 Hours Interval 4.0 to 8.0	6.00 Hours Interval 3.97 to 8.0	11.3 Hours Interval 0.0 to 22.5	6.00 Hours Interval 2.0 to 7.5	6.00 Hours Interval 3.9 to 7.95	—	—

SECONDARY outcome

Timeframe: Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose) (Cycle=28 days)

PK parameters were estimated from each individual plasma concentration-time profile using non-compartmental analysis. Apparent systemic plasma clearance rate of INC280 and gefitinib

Outcome measures

Outcome measures
Measure	INC280 100 mg Cap QD Phase Ib n=4 Participants cap=capsule; QD=once daily	INC280 200 mg Cap QD Phase Ib n=7 Participants cap=capsule; QD=once daily	INC280 400 mg Cap QD Phase Ib n=5 Participants cap=capsule; QD=once daily	INC280 800 mg Cap QD Phase Ib n=3 Participants cap=capsule; QD=once daily	INC280 200 mg Cap BID Phase Ib n=4 Participants cap=capsule; BID=twice daily	INC280 400 mg Cap BID Phase Ib n=10 Participants cap=capsule; BID=twice daily	INC280 600 mg Cap BID Phase Ib n=2 Participants cap=capsule; BID=twice daily	INC280 200 mg Tab BID Phase Ib n=7 Participants tab=tablet; BID=twice daily	INC280 400 mg Tab BID Phase Ib n=7 Participants tab=tablet; BID=twice daily	INC280 400 mg Cap BID Phase II cap=capsule; BID=twice daily	INC280 400 mg Tab BID Phase II tab=tablet; BID=twice daily
Phase I: PK Parameters Apparent Systemic Plasma Clearance Rate of INC280 and Gefitinib INC 280	26.9 L/hr Standard Deviation 15.0	29.4 L/hr Standard Deviation 15.7	16.3 L/hr Standard Deviation 7.61	47.7 L/hr Standard Deviation 49.1	27.0 L/hr Standard Deviation 14.7	24.2 L/hr Standard Deviation 18.3	18.4 L/hr Standard Deviation 9.31	15.4 L/hr Standard Deviation 3.89	14.4 L/hr Standard Deviation 3.10	—	—
Phase I: PK Parameters Apparent Systemic Plasma Clearance Rate of INC280 and Gefitinib Gefitinib	33.3 L/hr Standard Deviation 6.78	32.9 L/hr Standard Deviation 9.65	36.5 L/hr Standard Deviation 8.41	19.5 L/hr	30.8 L/hr Standard Deviation 8.61	41.0 L/hr Standard Deviation 24.1	—	36.9 L/hr Standard Deviation 8.81	32.5 L/hr Standard Deviation 4.99	—	—

SECONDARY outcome

Timeframe: Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose)(Cycle=28 days)

PK parameters were estimated from each individual plasma concentration-time profile using non-compartmental analysis. The elimination half-life of INC280 and gefitinib associated with the terminal slope (Lamda\_z) of a semi-logarithmic plasma concentration-time curve

Outcome measures

Outcome measures
Measure	INC280 100 mg Cap QD Phase Ib n=4 Participants cap=capsule; QD=once daily	INC280 200 mg Cap QD Phase Ib n=6 Participants cap=capsule; QD=once daily	INC280 400 mg Cap QD Phase Ib n=5 Participants cap=capsule; QD=once daily	INC280 800 mg Cap QD Phase Ib n=3 Participants cap=capsule; QD=once daily	INC280 200 mg Cap BID Phase Ib n=3 Participants cap=capsule; BID=twice daily	INC280 400 mg Cap BID Phase Ib n=9 Participants cap=capsule; BID=twice daily	INC280 600 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 200 mg Tab BID Phase Ib n=7 Participants tab=tablet; BID=twice daily	INC280 400 mg Tab BID Phase Ib n=6 Participants tab=tablet; BID=twice daily	INC280 400 mg Cap BID Phase II cap=capsule; BID=twice daily	INC280 400 mg Tab BID Phase II tab=tablet; BID=twice daily
Phase I: PK Parameters Half-life of INC280 and Gefitinib Gefitinib	18.8 hours	26.9 hours Standard Deviation 4.63	36.3 hours Standard Deviation 8.20	37.8 hours	16.3 hours Standard Deviation 2.16	18.7 hours Standard Deviation 7.75	—	17.8 hours Standard Deviation 5.08	23.9 hours	—	—
Phase I: PK Parameters Half-life of INC280 and Gefitinib INC280	3.86 hours Standard Deviation 0.564	5.10 hours Standard Deviation 2.01	3.16 hours Standard Deviation 0.361	3.67 hours Standard Deviation 0.796	3.19 hours Standard Deviation 0.942	3.01 hours Standard Deviation 1.38	—	3.75 hours Standard Deviation 1.94	3.17 hours Standard Deviation 0.783	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 15 of cycle 1 (Cycle=28days)

Population: Full analysis set patients in phase Ib with p cMET H score measured. Few tumor samples were available since tumor biopsy was optional for this study.

Inhibition of c-MET signaling by pre- and post- treatment immunohistochemistry of p-c-MET

Outcome measures

Outcome measures
Measure	INC280 100 mg Cap QD Phase Ib n=1 Participants cap=capsule; QD=once daily	INC280 200 mg Cap QD Phase Ib cap=capsule; QD=once daily	INC280 400 mg Cap QD Phase Ib cap=capsule; QD=once daily	INC280 800 mg Cap QD Phase Ib cap=capsule; QD=once daily	INC280 200 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 400 mg Cap BID Phase Ib n=3 Participants cap=capsule; BID=twice daily	INC280 600 mg Cap BID Phase Ib cap=capsule; BID=twice daily	INC280 200 mg Tab BID Phase Ib tab=tablet; BID=twice daily	INC280 400 mg Tab BID Phase Ib tab=tablet; BID=twice daily	INC280 400 mg Cap BID Phase II n=1 Participants cap=capsule; BID=twice daily	INC280 400 mg Tab BID Phase II tab=tablet; BID=twice daily
Phase I: Percentage of Change From Baseline in C-MET H Score at Cycle 1 Day 15	-100 Percentage Interval -100.0 to -100.0	—	—	—	—	-100 Percentage Interval -100.0 to -100.0	—	—	—	-31 Percentage Interval -31.0 to -31.0	—

Deaths: 6 deaths

400 mg Tab BID (Ph II)

Serious events: 19 serious events

Other events: 47 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	100 mg Cap QD (Ph Ib) n=5 participants at risk 100 mg Cap QD (Ph Ib)	200 mg Cap QD (Ph Ib) n=7 participants at risk 200 mg Cap QD (Ph Ib)	400 mg Cap QD (Ph Ib) n=6 participants at risk 400 mg Cap QD (Ph Ib)	800 mg Cap QD (Ph Ib) n=7 participants at risk 800 mg Cap QD (Ph Ib)	200 mg Cap BID (Ph Ib) n=4 participants at risk 200 mg Cap BID (Ph Ib)	400 mg Cap BID (Ph Ib) n=12 participants at risk 400 mg Cap BID (Ph Ib)	600 mg Cap BID (Ph Ib) n=5 participants at risk 600 mg Cap BID (Ph Ib)	200 mg Tab BID (Ph Ib) n=7 participants at risk 200 mg Tab BID (Ph Ib)	400 mg Tab BID (Ph Ib) n=8 participants at risk 400 mg Tab BID (Ph Ib)	400 mg Cap BID (Ph II) n=53 participants at risk 400 mg Cap BID (Ph II)	400 mg Tab BID (Ph II) n=47 participants at risk 400 mg Tab BID (Ph II)
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Cardiac disorders Angina pectoris	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Cardiac disorders Cardiac disorder	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Cardiac disorders Myocardial infarction	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Cardiac disorders Pericardial effusion	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Gastritis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Ileus	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Intestinal perforation	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Vomiting	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Asthenia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Oedema peripheral	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	4.3% 2/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Hepatobiliary disorders Cholecystitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Cellulitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	4.3% 2/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Device related infection	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Erysipelas	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Klebsiella infection	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Peritonitis bacterial	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Pneumonia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	7.5% 4/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	4.3% 2/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Pneumonia mycoplasmal	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Septic shock	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Tracheobronchitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Alanine aminotransferase increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Bilirubin conjugated increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood bilirubin increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood pressure decreased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peritumoural oedema	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Cerebrovascular accident	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Dizziness	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Haemorrhage intracranial	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Headache	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Intracranial pressure increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	3.8% 2/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Somnolence	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Spinal cord compression	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 2/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 2/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.4% 3/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Vascular disorders Haematoma	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Vascular disorders Orthostatic hypotension	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.

Other adverse events

Other adverse events
Measure	100 mg Cap QD (Ph Ib) n=5 participants at risk 100 mg Cap QD (Ph Ib)	200 mg Cap QD (Ph Ib) n=7 participants at risk 200 mg Cap QD (Ph Ib)	400 mg Cap QD (Ph Ib) n=6 participants at risk 400 mg Cap QD (Ph Ib)	800 mg Cap QD (Ph Ib) n=7 participants at risk 800 mg Cap QD (Ph Ib)	200 mg Cap BID (Ph Ib) n=4 participants at risk 200 mg Cap BID (Ph Ib)	400 mg Cap BID (Ph Ib) n=12 participants at risk 400 mg Cap BID (Ph Ib)	600 mg Cap BID (Ph Ib) n=5 participants at risk 600 mg Cap BID (Ph Ib)	200 mg Tab BID (Ph Ib) n=7 participants at risk 200 mg Tab BID (Ph Ib)	400 mg Tab BID (Ph Ib) n=8 participants at risk 400 mg Tab BID (Ph Ib)	400 mg Cap BID (Ph II) n=53 participants at risk 400 mg Cap BID (Ph II)	400 mg Tab BID (Ph II) n=47 participants at risk 400 mg Tab BID (Ph II)
Blood and lymphatic system disorders Anaemia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 2/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	34.0% 18/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.5% 4/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Blood and lymphatic system disorders Leukopenia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.4% 5/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	7.5% 4/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Cardiac disorders Cardiac failure congestive	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Cardiac disorders Tachycardia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Ear and labyrinth disorders Hypoacusis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	4.3% 2/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Ear and labyrinth disorders Tinnitus	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Dry eye	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	4.3% 2/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Eye irritation	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Lacrimation increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	28.6% 2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Photopsia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Vision blurred	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Visual acuity reduced	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Abdominal distension	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.7% 3/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 2/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.5% 4/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 2/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.5% 4/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Constipation	60.0% 3/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	28.6% 2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.4% 5/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	23.4% 11/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Diarrhoea	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	28.6% 2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	75.0% 3/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 4/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	37.5% 3/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	13.2% 7/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	31.9% 15/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Dry mouth	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	4.3% 2/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.4% 3/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Gastric ulcer	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Gastritis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	4.3% 2/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Gingival bleeding	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.7% 3/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Mouth ulceration	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	3.8% 2/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Nausea	40.0% 2/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	28.6% 2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 3/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	85.7% 6/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 2/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	71.4% 5/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	37.5% 3/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	13.2% 7/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	55.3% 26/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Stomatitis	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.4% 3/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Vomiting	40.0% 2/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	42.9% 3/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 2/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	100.0% 7/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	28.6% 2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	37.5% 3/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.9% 10/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	21.3% 10/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Asthenia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	28.6% 2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.7% 3/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.5% 4/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Chest discomfort	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Face oedema	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Fatigue	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 2/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.9% 10/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	36.2% 17/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Generalised oedema	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Influenza like illness	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Mucosal inflammation	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Non-cardiac chest pain	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	28.6% 2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.1% 8/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.5% 4/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Oedema	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 2/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.4% 3/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Oedema peripheral	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 2/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 4/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 2/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	42.9% 3/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 2/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	28.3% 15/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	44.7% 21/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Pain	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Peripheral swelling	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.4% 3/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Pyrexia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	3.8% 2/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.5% 4/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Cellulitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.4% 3/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Conjunctivitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	4.3% 2/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Cystitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	42.9% 3/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Ear infection	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Eye infection	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Folliculitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Gastroenteritis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Infected dermal cyst	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Influenza	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Localised infection	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Nasopharyngitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.4% 5/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Paronychia	40.0% 2/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 2/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 2/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 4/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	28.6% 2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	37.5% 3/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	13.2% 7/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	21.3% 10/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Periodontitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Pneumonia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Rhinitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Skin infection	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Upper respiratory tract infection	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	3.8% 2/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.5% 4/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Urinary tract infection	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.5% 4/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Tracheal haemorrhage	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Wound complication	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Alanine aminotransferase increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	24.5% 13/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.6% 5/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Amylase increased	40.0% 2/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 4/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	28.6% 2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	13.2% 7/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	23.4% 11/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Aspartate aminotransferase increased	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.9% 10/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.9% 7/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Bilirubin conjugated increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.4% 5/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood albumin decreased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	3.8% 2/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood alkaline phosphatase increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	3.8% 2/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.5% 4/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood bilirubin increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	41.7% 5/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.1% 8/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.5% 4/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood creatinine increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 3/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	28.6% 2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	17.0% 9/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	17.0% 8/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood glucose increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood iron decreased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood phosphorus increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Crystal urine present	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Gamma-glutamyltransferase increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.7% 3/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.6% 5/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Haemoglobin decreased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.7% 3/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Lipase increased	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.4% 5/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	21.3% 10/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Neutrophil count decreased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Protein total increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Protein urine present	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 2/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	3.8% 2/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Urinary sediment present	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Urine analysis abnormal	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Urine bilirubin increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Urine ketone body present	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Urobilinogen urine increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Weight decreased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 2/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.5% 4/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Weight increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.4% 3/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations White blood cell count decreased	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	3.8% 2/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations White blood cells urine positive	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Decreased appetite	40.0% 2/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	28.6% 2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	57.1% 4/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	60.0% 3/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	42.9% 3/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	37.5% 3/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	24.5% 13/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.4% 19/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hyperamylasaemia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.1% 8/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	3.8% 2/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.5% 4/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hyperkalaemia	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	28.6% 2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	75.0% 3/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	58.3% 7/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	43.4% 23/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.5% 12/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.1% 8/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.4% 3/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	3.8% 2/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	13.2% 7/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.5% 4/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	4.3% 2/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	28.6% 2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.3% 6/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.7% 3/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 2/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.4% 5/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.4% 3/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	57.1% 4/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	7.5% 4/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.5% 4/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	3.8% 2/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Flank pain	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Ligament pain	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 2/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.4% 3/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	3.8% 2/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	3.8% 2/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.7% 3/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.4% 3/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	4.3% 2/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Cognitive disorder	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Depressed level of consciousness	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Dizziness	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	28.6% 2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 2/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 2/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.3% 6/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.4% 3/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Dyskinesia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Facial spasm	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Headache	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	37.5% 3/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.7% 3/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	17.0% 8/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Hypoaesthesia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Nervous system disorder	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Neuropathy peripheral	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	4.3% 2/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Paraesthesia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Taste disorder	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Tremor	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	3.8% 2/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Psychiatric disorders Anxiety	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Psychiatric disorders Depression	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Psychiatric disorders Insomnia	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	42.9% 3/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	13.2% 7/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	4.3% 2/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Renal and urinary disorders Azotaemia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Renal and urinary disorders Dysuria	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.4% 3/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Renal and urinary disorders Haematuria	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.4% 5/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	4.3% 2/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Renal and urinary disorders Haemoglobinuria	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Renal and urinary disorders Pollakiuria	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Renal and urinary disorders Proteinuria	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	3.8% 2/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 2/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 3/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	60.0% 3/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	26.4% 14/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	17.0% 8/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	28.6% 2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 4/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 2/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.7% 3/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	19.1% 9/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.1% 8/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	4.3% 2/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	7.5% 4/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.5% 4/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 2/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Acne	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.4% 3/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Dermatitis acneiform	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	28.6% 2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	57.1% 4/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.6% 5/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Dermatosis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	28.6% 2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	1.9% 1/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.5% 4/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Pruritus	60.0% 3/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	3.8% 2/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.6% 5/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Rash	40.0% 2/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	42.9% 3/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	28.6% 2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 2/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 4/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	28.6% 2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	37.5% 3/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	13.2% 7/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	31.9% 15/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Rash vesicular	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	2.1% 1/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Vascular disorders Deep vein thrombosis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Vascular disorders Hypotension	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Vascular disorders Orthostatic hypotension	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	14.3% 1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Vascular disorders Peripheral vascular disorder	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 1/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Vascular disorders Phlebitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/8 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/53 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/47 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 8 years. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER