Trial Outcomes & Findings for A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer (NCT NCT02276027)

NCT ID: NCT02276027

Last Updated: 2020-12-16

Results Overview

Overall response rate is the proportion of patients with a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria (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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 66 participants
• Primary outcome timeframe: Up to 231 weeks
• Results posted on: 2020-12-16

Participant Flow

Participants were from China

To enter the screening phase, the subjects' molecular alterations were determined using locally validated methodologies from a newly obtained tumor sample or the most recent archival tumor sample available. Based on the molecular alterations of the tumor, subjects were assigned to one of the treatment arms. Subjects with multiple molecular alterations in epidermal growth factor receptor and the relevant pathways were excluded, except under the conditions described in Inclusion criteria.

Participant milestones

Measure	BYL719 350 mg QD Patient's tumor must have molecular alteration of the PIK3CA gene.	INC280 400 mg BID Tab/600 mg BID Cap Patient's tumor must have molecular alteration of the c-MET gene.	LDK378 750 mg QD Patient's tumor must have ALK or ROS1 gene rearrangement.	MEK162 45 mg BID Patient's tumor must have KRAS, NRAS or BRAF mutation.
Overall Study STARTED	2	16	26	22
Overall Study COMPLETED	0	0	6	0
Overall Study NOT COMPLETED	2	16	20	22

Reasons for withdrawal

Measure	BYL719 350 mg QD Patient's tumor must have molecular alteration of the PIK3CA gene.	INC280 400 mg BID Tab/600 mg BID Cap Patient's tumor must have molecular alteration of the c-MET gene.	LDK378 750 mg QD Patient's tumor must have ALK or ROS1 gene rearrangement.	MEK162 45 mg BID Patient's tumor must have KRAS, NRAS or BRAF mutation.
Overall Study Death	1	0	0	2
Overall Study Physician Decision	0	0	0	1
Overall Study Progressive disease	1	13	12	14
Overall Study Subject/guardian decision	0	1	0	3
Overall Study Adverse Event	0	2	8	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	BYL719 350 mg QD n=2 Participants Patient's tumor must have molecular alteration of the PIK3CA gene.	INC280 400 mg BID Tab/600 mg BID Cap n=16 Participants Patient's tumor must have molecular alteration of the c-MET gene.	LDK378 750 mg QD n=26 Participants Patient's tumor must have ALK or ROS1 gene rearrangement.	MEK162 45 mg BID n=22 Participants Patient's tumor must have KRAS, NRAS or BRAF mutation.	Total n=66 Participants Total of all reporting groups
Sex: Female, Male Female	0 Participants n=2 Participants	5 Participants n=16 Participants	15 Participants n=26 Participants	3 Participants n=22 Participants	23 Participants n=66 Participants
Age, Continuous	53.0 years n=2 Participants	58.2 years n=16 Participants	49.4 years n=26 Participants	60.3 years n=22 Participants	55.3 years n=66 Participants
Sex: Female, Male Male	2 Participants n=2 Participants	11 Participants n=16 Participants	11 Participants n=26 Participants	19 Participants n=22 Participants	43 Participants n=66 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Up to 231 weeks

Population: Full analysis set: all subjects who received at least one dose of the respective study treatment.

Overall response rate is the proportion of patients with a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria (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

Measure	BYL719 350 mg QD n=2 Participants Patient's tumor must have molecular alteration of the PIK3CA gene.	INC280 400 mg BID Tab/600 mg BID Cap n=16 Participants Patient's tumor must have molecular alteration of the c-MET gene.	LDK378 750 mg QD n=26 Participants Patient's tumor must have ALK or ROS1 gene rearrangement.	MEK162 45 mg BID n=22 Participants Patient's tumor must have KRAS, NRAS or BRAF mutation.
Overall Response Rate (ORR)	0 Participants	3 Participants	19 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 231 weeks

Population: Full analysis set: all subjects who received at least one dose of the respective study treatment.

OS is defined as the time from date of randomization/start of treatment to date of death due to any cause.

Outcome measures

Measure	BYL719 350 mg QD n=2 Participants Patient's tumor must have molecular alteration of the PIK3CA gene.	INC280 400 mg BID Tab/600 mg BID Cap n=16 Participants Patient's tumor must have molecular alteration of the c-MET gene.	LDK378 750 mg QD n=26 Participants Patient's tumor must have ALK or ROS1 gene rearrangement.	MEK162 45 mg BID n=22 Participants Patient's tumor must have KRAS, NRAS or BRAF mutation.
Median Overall Survival (OS)	4.99 Months Interval 0.3 to 9.69	13.26 Months Interval 1.18 to 23.33	NA Months Interval 19.35 to Median and upper limit NA because they are not evaluable. The median OS was not reached	9.20 Months Interval 3.52 to 11.93

SECONDARY outcome

Timeframe: Up to 231 weeks

Population: Full analysis set: all subjects who received at least one dose of the respective study treatment.

PFS event is defined as the first documented progression or death due to any cause according to RECIST 1.1 criteria

Outcome measures

Measure	BYL719 350 mg QD n=2 Participants Patient's tumor must have molecular alteration of the PIK3CA gene.	INC280 400 mg BID Tab/600 mg BID Cap n=16 Participants Patient's tumor must have molecular alteration of the c-MET gene.	LDK378 750 mg QD n=26 Participants Patient's tumor must have ALK or ROS1 gene rearrangement.	MEK162 45 mg BID n=22 Participants Patient's tumor must have KRAS, NRAS or BRAF mutation.
Number of Participants With Progression-free Survival (PFS)	2 Participants	16 Participants	19 Participants	19 Participants

SECONDARY outcome

Timeframe: Up to 231 weeks

Population: Full analysis set: all subjects who received at least one dose of the respective study treatment.

DCR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR) or Stable Disease (SD) according to RECIST 1.1 criteria (DCR: CR+PR+SD) 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.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD

Outcome measures

Measure	BYL719 350 mg QD n=2 Participants Patient's tumor must have molecular alteration of the PIK3CA gene.	INC280 400 mg BID Tab/600 mg BID Cap n=16 Participants Patient's tumor must have molecular alteration of the c-MET gene.	LDK378 750 mg QD n=26 Participants Patient's tumor must have ALK or ROS1 gene rearrangement.	MEK162 45 mg BID n=22 Participants Patient's tumor must have KRAS, NRAS or BRAF mutation.
Disease Control Rate (DCR)	50.0 Percentage of participants Interval 1.3 to 98.7	43.8 Percentage of participants Interval 19.8 to 70.1	92.3 Percentage of participants Interval 74.9 to 99.1	59.1 Percentage of participants Interval 36.4 to 79.3

SECONDARY outcome

Timeframe: Up to 231 weeks

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

Duration of overall response (DOR) is defined as the time from the first documented CR or PR (confirmed by the subsequent assessment) to the date of the first documented progression or death due to underlying cancer.

Outcome measures

Measure	BYL719 350 mg QD Patient's tumor must have molecular alteration of the PIK3CA gene.	INC280 400 mg BID Tab/600 mg BID Cap n=3 Participants Patient's tumor must have molecular alteration of the c-MET gene.	LDK378 750 mg QD n=19 Participants Patient's tumor must have ALK or ROS1 gene rearrangement.	MEK162 45 mg BID n=2 Participants Patient's tumor must have KRAS, NRAS or BRAF mutation.
Median Duration of Overall Response (DOR)	—	3.84 Months Interval 3.81 to 5.59	34.96 Months Interval 7.59 to Upper limit NA because it is not evaluable	5.47 Months Interval 3.55 to 7.39

SECONDARY outcome

Timeframe: up to 235 weeks

Population: Safety Set: Includes all patients who received at least one dose of the respective study medication and had at least one valid postbaseline safety assessment.

Adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

If CTCAE grading does not exist for an adverse event, the severity of mild, moderate, severe, and life-threatening, corresponding to grades 1 - 4, was used.

Outcome measures

Measure	BYL719 350 mg QD n=2 Participants Patient's tumor must have molecular alteration of the PIK3CA gene.	INC280 400 mg BID Tab/600 mg BID Cap n=16 Participants Patient's tumor must have molecular alteration of the c-MET gene.	LDK378 750 mg QD n=26 Participants Patient's tumor must have ALK or ROS1 gene rearrangement.	MEK162 45 mg BID n=22 Participants Patient's tumor must have KRAS, NRAS or BRAF mutation.
Number of Participants With Adverse Events AE All grades	2 Participants	16 Participants	26 Participants	22 Participants
Number of Participants With Adverse Events AE Grade 3/4	1 Participants	11 Participants	23 Participants	20 Participants
Number of Participants With Adverse Events SAE All grades	1 Participants	12 Participants	11 Participants	18 Participants
Number of Participants With Adverse Events SAE Grade 3/4	1 Participants	7 Participants	9 Participants	15 Participants

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours) and Day 15 (pre dose, 0.5, 1, 2, 4, 6, 8 hours post dose and only for BYL719 350 mg QD and LDK378 750 mg QD arms also at 24 hours post dose)

Population: PAS: Pharmacokinetic analysis set includes all subjects who have at least one blood sample providing evaluable PK data.

PK parameters are estimated from each individual plasma concentration-time profile using non-compartmental analysis (Phoenix software version 6.2 and above).

AUCtau is the AUC calculated to the end of a dosing interval (tau) (amount x time x volume-1) AUClast is the AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1) On Cycle 1 Day 1, PK parameters for only BYL719 350 mg QD arm were analyzed

Outcome measures

Measure	BYL719 350 mg QD n=2 Participants Patient's tumor must have molecular alteration of the PIK3CA gene.	INC280 400 mg BID Tab/600 mg BID Cap n=14 Participants Patient's tumor must have molecular alteration of the c-MET gene.	LDK378 750 mg QD n=6 Participants Patient's tumor must have ALK or ROS1 gene rearrangement.	MEK162 45 mg BID n=9 Participants Patient's tumor must have KRAS, NRAS or BRAF mutation.
Pharmacokinetics Profile, AUCtau and AUClast AUClast Cycle 1 Day 1	20909 ng*h/mL Standard Deviation 107	—	—	—
Pharmacokinetics Profile, AUCtau and AUClast AUCtau Cycle 1 Day 15	23892 ng*h/mL Standard Deviation NA SD is NA since there is only 1 subject with evaluable PK profile	32034 ng*h/mL Standard Deviation 6992	30361 ng*h/mL Standard Deviation 3807	2645 ng*h/mL Standard Deviation 981
Pharmacokinetics Profile, AUCtau and AUClast AUClast Cycle 1 Day 15	23721 ng*h/mL Standard Deviation NA SD is NA since there is only 1 subject with evaluable PK profile	27875 ng*h/mL Standard Deviation 7629	28013 ng*h/mL Standard Deviation 5006	2642 ng*h/mL Standard Deviation 1026

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours) and Day 15 (pre dose, 0.5, 1, 2, 4, 6, 8 hours post dose and only for BYL719 350 mg QD and LDK378 750 mg QD arms also at 24 hours post dose)

Population: PAS: Pharmacokinetic analysis set includes all subjects who have at least one blood sample providing evaluable PK data.

PK parameters are estimated from each individual plasma concentration-time profile using non-compartmental analysis (Phoenix software version 6.2 and above).

Cmax is the maximum (peak) observed plasma concentration (mass x volume-1) On Cycle 1 Day 1, PK parameters for only BYL719 350 mg QD arm were analyzed

Outcome measures

Measure	BYL719 350 mg QD n=2 Participants Patient's tumor must have molecular alteration of the PIK3CA gene.	INC280 400 mg BID Tab/600 mg BID Cap n=14 Participants Patient's tumor must have molecular alteration of the c-MET gene.	LDK378 750 mg QD n=6 Participants Patient's tumor must have ALK or ROS1 gene rearrangement.	MEK162 45 mg BID n=9 Participants Patient's tumor must have KRAS, NRAS or BRAF mutation.
Pharmacokinetics Profile, Cmax Cmax Cycle 1 Day 1	2135 ng/mL Standard Deviation 700	—	—	—
Pharmacokinetics Profile, Cmax Cmax Cycle 1 Day 15	2630 ng/mL Standard Deviation NA SD is NA since there is only 1 subject with evaluable PK profile	8046 ng/mL Standard Deviation 3550	1362 ng/mL Standard Deviation 177	587 ng/mL Standard Deviation 183

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours) and Day 15 (pre dose, 0.5, 1, 2, 4, 6, 8 hours post dose and only for BYL719 350 mg QD and LDK378 750 mg QD arms also at 24 hours post dose)

Population: PAS: Pharmacokinetic analysis set includes all subjects who have at least one blood sample providing evaluable PK data.

PK parameters are estimated from each individual plasma concentration-time profile using non-compartmental analysis (Phoenix software version 6.2 and above).

Tmax is the time to reach maximum (peak) plasma concentration (time) On Cycle 1 Day 1, PK parameters for only BYL719 350 mg QD arm were analyzed

Outcome measures

Measure	BYL719 350 mg QD n=2 Participants Patient's tumor must have molecular alteration of the PIK3CA gene.	INC280 400 mg BID Tab/600 mg BID Cap n=14 Participants Patient's tumor must have molecular alteration of the c-MET gene.	LDK378 750 mg QD n=6 Participants Patient's tumor must have ALK or ROS1 gene rearrangement.	MEK162 45 mg BID n=9 Participants Patient's tumor must have KRAS, NRAS or BRAF mutation.
Pharmacokinetics Profile, Tmax Tmax Cycle 1 Day 1	4.03 hours Interval 2.05 to 6.0	—	—	—
Pharmacokinetics Profile, Tmax Tmax Cycle 1 Day 15	2.00 hours Interval 2.0 to 2.0	1.00 hours Interval 0.467 to 6.17	6.10 hours Interval 2.03 to 8.0	1.10 hours Interval 0.517 to 7.58

Adverse Events

BYL719 350 mg QD

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

INC280 400 mg BID Tab/600 mg BID Cap

Serious events: 12 serious events

Other events: 16 other events

Deaths: 4 deaths

LDK378 750 mg QD

Serious events: 11 serious events

Other events: 26 other events

Deaths: 1 deaths

MEK162 45 mg BID

Serious events: 18 serious events

Other events: 22 other events

Deaths: 5 deaths

Serious adverse events

Measure	BYL719 350 mg QD n=2 participants at risk Patient's tumor must have molecular alteration of the PIK3CA gene.	INC280 400 mg BID Tab/600 mg BID Cap n=16 participants at risk Patient's tumor must have molecular alteration of the c-MET gene.	LDK378 750 mg QD n=26 participants at risk Patient's tumor must have ALK or ROS1 gene rearrangement.	MEK162 45 mg BID n=22 participants at risk Patient's tumor must have KRAS, NRAS or BRAF mutation.
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Cardiac disorders Rheumatic heart disease	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
General disorders Asthenia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
General disorders Non-cardiac chest pain	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
General disorders Pyrexia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	13.6% 3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Infections and infestations Appendicitis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Infections and infestations Bronchitis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Infections and infestations Pneumonia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	11.5% 3/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	18.2% 4/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Infections and infestations Pulmonary tuberculosis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Alanine aminotransferase increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Blood alkaline phosphatase increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Blood creatine phosphokinase increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	18.2% 4/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Gamma-glutamyltransferase increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Nervous system disorders Loss of consciousness	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	31.2% 5/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	18.2% 4/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	13.6% 3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Vascular disorders Deep vein thrombosis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Vascular disorders Venous thrombosis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.

Other adverse events

Measure	BYL719 350 mg QD n=2 participants at risk Patient's tumor must have molecular alteration of the PIK3CA gene.	INC280 400 mg BID Tab/600 mg BID Cap n=16 participants at risk Patient's tumor must have molecular alteration of the c-MET gene.	LDK378 750 mg QD n=26 participants at risk Patient's tumor must have ALK or ROS1 gene rearrangement.	MEK162 45 mg BID n=22 participants at risk Patient's tumor must have KRAS, NRAS or BRAF mutation.
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	31.2% 5/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	15.4% 4/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	13.6% 3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	81.2% 13/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	73.1% 19/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	81.8% 18/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Blood and lymphatic system disorders Leukopenia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	15.4% 4/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Cardiac disorders Atrioventricular block first degree	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Cardiac disorders Atrioventricular dissociation	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Cardiac disorders Bradycardia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Cardiac disorders Bundle branch block right	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Cardiac disorders Nodal rhythm	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Cardiac disorders Palpitations	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Cardiac disorders Pericardial effusion	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Cardiac disorders Sinus bradycardia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	19.2% 5/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Cardiac disorders Sinus tachycardia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Cardiac disorders Supraventricular tachycardia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Cardiac disorders Tachycardia	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Cardiac disorders Ventricular extrasystoles	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Cardiac disorders Ventricular tachycardia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Cardiac disorders Wandering pacemaker	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Ear and labyrinth disorders Deafness unilateral	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Ear and labyrinth disorders Motion sickness	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Ear and labyrinth disorders Tinnitus	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	26.9% 7/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Eye disorders Cataract	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Eye disorders Eye disorder	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Eye disorders Eyelid oedema	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Eye disorders Ocular discomfort	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Eye disorders Scleritis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Eye disorders Vision blurred	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	11.5% 3/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Eye disorders Visual impairment	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Eye disorders Vitreous floaters	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Abdominal distension	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	15.4% 4/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	42.3% 11/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	76.9% 20/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	13.6% 3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Abnormal faeces	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	13.6% 3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Chronic gastritis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Constipation	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	18.8% 3/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	15.4% 4/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	31.8% 7/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	25.0% 4/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	100.0% 26/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	63.6% 14/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	11.5% 3/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	22.7% 5/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Faeces hard	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Gastric dilatation	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Gingival bleeding	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Haemorrhoids	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Mouth ulceration	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	36.4% 8/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Nausea	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	37.5% 6/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	46.2% 12/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	27.3% 6/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Oesophageal oedema	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Oesophagitis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Toothache	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	37.5% 6/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	76.9% 20/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	40.9% 9/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
General disorders Asthenia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	38.5% 10/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	31.8% 7/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
General disorders Chest discomfort	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	31.2% 5/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	19.2% 5/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
General disorders Chills	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
General disorders Face oedema	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	22.7% 5/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
General disorders Fatigue	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	11.5% 3/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	13.6% 3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
General disorders Impaired healing	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
General disorders Influenza like illness	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
General disorders Injection site swelling	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
General disorders Malaise	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
General disorders Non-cardiac chest pain	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	31.2% 5/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	46.2% 12/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
General disorders Oedema peripheral	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	31.2% 5/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	15.4% 4/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	50.0% 11/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
General disorders Pain	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
General disorders Pyrexia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	31.2% 5/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	26.9% 7/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	45.5% 10/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
General disorders Sensation of foreign body	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
General disorders Swelling face	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Immune system disorders Anaphylactic reaction	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Infections and infestations Abscess	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Infections and infestations Appendicitis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Infections and infestations Cellulitis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Infections and infestations Chronic sinusitis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Infections and infestations Conjunctivitis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Infections and infestations Erythrasma	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Infections and infestations Herpes zoster	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Infections and infestations Nasopharyngitis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	15.4% 4/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Infections and infestations Paronychia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Infections and infestations Pneumonia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	18.8% 3/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	13.6% 3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Infections and infestations Respiratory tract infection	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Infections and infestations Tonsillitis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	19.2% 5/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Infections and infestations Urethritis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Infections and infestations Urinary tract infection	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Injury, poisoning and procedural complications Skin injury	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Injury, poisoning and procedural complications Wound complication	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Alanine aminotransferase increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	43.8% 7/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	92.3% 24/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	27.3% 6/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Albumin urine present	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	18.8% 3/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Alpha hydroxybutyrate dehydrogenase increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Amylase increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	43.8% 7/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	30.8% 8/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	27.3% 6/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Aspartate aminotransferase increased	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	31.2% 5/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	100.0% 26/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	72.7% 16/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Bilirubin conjugated increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	18.8% 3/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	26.9% 7/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Blood albumin decreased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Blood alkaline phosphatase increased	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	31.2% 5/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	57.7% 15/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	27.3% 6/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Blood bilirubin increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	31.2% 5/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	11.5% 3/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	13.6% 3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Blood cholesterol increased	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Blood creatine increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Blood creatine phosphokinase MB increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Blood creatine phosphokinase increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	26.9% 7/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	72.7% 16/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Blood creatinine increased	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	43.8% 7/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	38.5% 10/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Blood fibrinogen increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Blood glucose increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Blood lactate dehydrogenase increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Blood phosphorus decreased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Blood pressure increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Blood triglycerides increased	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	15.4% 4/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Blood urea increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Blood uric acid increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	13.6% 3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Electrocardiogram QT prolonged	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	38.5% 10/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	27.3% 6/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Electrocardiogram T wave abnormal	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Enzyme level increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Gamma-glutamyltransferase increased	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	56.2% 9/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	57.7% 15/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	18.2% 4/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Glucose urine present	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Haemoglobin increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations International normalised ratio increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Lipase increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	19.2% 5/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	13.6% 3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Neutrophil count decreased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations PO2 decreased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Platelet count decreased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Platelet count increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Protein total decreased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	13.6% 3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Protein urine present	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Prothrombin time prolonged	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Red blood cell count decreased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Red blood cell count increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Red blood cells urine positive	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Thrombin time prolonged	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Troponin I increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	13.6% 3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Weight decreased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	57.7% 15/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations Weight increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations White blood cell count decreased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Investigations White blood cells urine positive	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Metabolism and nutrition disorders Acidosis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Metabolism and nutrition disorders Alkalosis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	56.2% 9/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	53.8% 14/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	36.4% 8/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	18.8% 3/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	15.4% 4/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	31.2% 5/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	34.6% 9/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Metabolism and nutrition disorders Hypermagnesaemia	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Metabolism and nutrition disorders Hypernatraemia	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	18.8% 3/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	26.9% 7/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Metabolism and nutrition disorders Hyperuricaemia	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	31.2% 5/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	65.4% 17/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	18.2% 4/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	100.0% 2/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	87.5% 14/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	80.8% 21/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	59.1% 13/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	25.0% 4/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	15.4% 4/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	36.4% 8/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	11.5% 3/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	30.8% 8/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	22.7% 5/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Metabolism and nutrition disorders Hyponatraemia	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	37.5% 6/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	34.6% 9/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	45.5% 10/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Metabolism and nutrition disorders Hypophosphataemia	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	30.8% 8/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	13.6% 3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	46.2% 12/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	15.4% 4/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	18.8% 3/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	11.5% 3/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	18.8% 3/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Nervous system disorders Ageusia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Nervous system disorders Dizziness	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	25.0% 4/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	34.6% 9/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	18.2% 4/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Nervous system disorders Dreamy state	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Nervous system disorders Dysgeusia	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Nervous system disorders Headache	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	23.1% 6/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Nervous system disorders Hypoaesthesia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	11.5% 3/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Nervous system disorders Intracranial pressure increased	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Nervous system disorders Neuralgia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Nervous system disorders Paraesthesia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Nervous system disorders Seizure	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Nervous system disorders Somnolence	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Nervous system disorders Speech disorder	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Nervous system disorders Taste disorder	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Psychiatric disorders Agitation	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Psychiatric disorders Depression	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Psychiatric disorders Dysphoria	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Psychiatric disorders Insomnia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	15.4% 4/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Psychiatric disorders Nervousness	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Psychiatric disorders Tic	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Renal and urinary disorders Dysuria	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Renal and urinary disorders Pollakiuria	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Renal and urinary disorders Proteinuria	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Renal and urinary disorders Urinary retention	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Reproductive system and breast disorders Menstrual disorder	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	65.4% 17/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	18.2% 4/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	56.2% 9/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	23.1% 6/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	31.8% 7/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	18.8% 3/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	13.6% 3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pharyngeal ulceration	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	18.8% 3/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	31.2% 5/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	34.6% 9/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	13.6% 3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	11.5% 3/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	12.5% 2/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	18.8% 3/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	26.9% 7/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	18.2% 4/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	46.2% 12/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	72.7% 16/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Vascular disorders Flushing	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Vascular disorders Hypertension	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	7.7% 2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	18.2% 4/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Vascular disorders Hypotension	50.0% 1/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Vascular disorders Hypovolaemic shock	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	3.8% 1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Vascular disorders Shock	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
Vascular disorders Superior vena cava syndrome	0.00% 0/2 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	6.2% 1/16 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks. Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: novartis.email@novartis.com

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